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Dreyer's Grand Ice Cream logo
Dreyer's Grand Ice CreamLaurel, MD
Are you looking to catapult your career by driving high-impact transformation with household brands? Do you crave an entrepreneurial, fast paced and engaging growth assignment working with incredible people from across the globe? At Dreyer's Grand Ice Cream, we are excited to start a new chapter of accelerated growth as part of Froneri - a global pure-play ice cream leader. Come help us transform DGIC into the #1 ice cream brand! With nearly 100 years of winning experience in the U.S, a robust portfolio of powerhouse brands that consumers know and love such as Häagen-Dazs, Drumstick, Dreyer's & Edy's, and the backing and coaching of European-based ice cream experts, we know we have the winning recipe. Headquartered in Walnut Creek, the Bay Area's hub for up-and-coming food trends, our teams across our offices and factories are raising the bar on all things ice cream. We are investing in significant capital expansions to grow our Operations and Supply chain and are transforming how we work at every level to become agile, accelerate growth and elevate our quality. With a renewed focus on frozen treats, our tight-knit team of ambitious innovators are fully immersed in the business and encouraged to flex and make decisions quickly. We are committed to pursuing every great idea and delivering the best ice cream experience for our consumers, when and where they want it. Unleash your potential at Dreyer's Grand Ice Cream and discover what a sweet career we have in store for you! Developing high quality standards and ownership across value chain Job Description: The Quality Supervisor ensures compliance with food safety regulations, monitors production processes, and implements quality control measures to maintain the highest standards in ice cream production. They work closely with production, R&D, and regulatory teams to ensure consistency and excellence in the final product. Lead by example to carry out all duties and specific responsibilities operational Quality and Food Safety Policies and Procedures. Promote the culture change towards behavioral quality improvements Provide expertise to operations for promoting and executing quality to provide customers with exceptional ice cream experience Direct and supervise the quality specialists and quality techs to ensure daily activities promote production of quality ice cream products on the lines Partner with operations management on key quality checks to be completed by line operators. Checks need to be evaluated periodically to ensure they are in line with hold and complaint data. Manage quality hold program and partner with operations to complete lesson learnt (root cause) and implement corrective action identified. Provide trend data to demonstrate effectiveness of corrective action implementation. Provide leadership on customer complaint reduction by partnering with operations on strategies to reduce complaints by using complaint trend data to prioritize actions. Oversee and provide leadership on the net content to establish facility specific rules to ensure compliance to both volume and weight targets Provide support to TAG on new product launches or formulation when requested. Identify, communicate to plant operations and apply "Best Practices" within the facility or from the broader network. Drive improvements and monitor Quality Metrics/KPI's at the facility Challenge all departments on quality and food safety related Provide support to GMP and HACCP, FSMA FSP compliance through out the facility, by coaching operators when on the floor and promoting minimal water use during production. Ensure compliance to internal and external audits i.e. FSSC 22000/Market audits Provide support to local, State and Federal agencies when requested by local quality management Drive Monthly reviews of KPI's and contribute towards meeting the yearly business goals for the facility. Monitor and assess performance of the quality systems, report their effectiveness to management and implement actions for improvement Represent The Froneri Way of working through the behaviors and characteristics in our Operating Model and Core Values Measurable Outcomes CPMU reduction Respect of GMP and distribution of the "lesson learnt " Reduction of pallets on holds Reduction of food safety incidents Being on the shop floor making ice-cream Drive improvements from benchmarking improvements Levels of responsibility Deploy QA standards Achieve QA targets defined at market level (CPMU, RFT, CRQS…) Hold program Net Content execution Qualifications & Requirements: Bachelor's degree in Food Science, Microbiology, or a related field. 2+ years of experience in quality assurance, preferably in the dairy or frozen food industry. Knowledge of HACCP, GMP, and food safety regulations. Strong attention to detail and problem-solving skills. Ability to lead a team and work collaboratively across departments. Proficiency in quality control software and reporting tools. BEHAVIORS AND CORE VALUES: Must consistently showcase the desired behaviors that represent our Core Values. We Take Ownership Stay committed to responsibilities from start to finish Make sound decisions and get into the right level of detail Apply resources to initiatives that add growth, improve efficiencies, or reduce waste We Do What Is Right Choose transparency over convenience, even if it means difficult conversations Set clear roles and responsibilities, enabling everyone to exercise appropriate initiative and judgment Speak up when you see something that does not align to our values and policies We Seek to Improve Strive to continuously improve and innovate to exceed expectations Value feedback from others and encourage open dialogue to understand how we can improve Learn from both successes and failures We Are Better Together Ensure decisions are based on what's best for the whole business Practice inclusion by seeking diverse perspectives Treat everyone with fairness and respect Work Environment In this position, the employee will regularly work with and around others; in a wet and/or humid environment; in areas of high noise level; and around mechanical, electrical, and pressurized equipment. The work is fast paced. Cold Temperatures: Parts of the facility, such as storage and production areas, may be kept at low temperatures. Requires use of cold-protective PPE. May involve standing, lifting, and walking in refrigerated zones for extended periods. Fast-Paced: Workers often operate under strict timelines to meet production quotas. High-speed manufacturing floor with frequent movement, line assignment changes, and tight production timelines. Standing for Long Hours: Many roles require prolonged standing and repetitive tasks. Repetitive hand and arm movements required. Must be able to stand for hours with frequent bending, reaching, and lifting. Food Safety Regulations: Employees must follow hygiene and safety guidelines, including wearing protective gear (gloves, hairnets, etc.). Team-Oriented: Workers collaborate to ensure smooth production and packaging. The position involves frequent exposure to nuts and other potential allergens. The pay scale for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. At Dreyer's Grand Ice Cream, it is not typical for an individual to be hired at or near the top of the range for their role, and compensation decisions are dependent on the facts and circumstances of each case. The pay range for prospective employees in this role is between $75,000.00 and $90,000.00 per year, with opportunities for overtime, shift differential, cold premium pay and annual bonuses (variable depending on company performance). We offer a comprehensive group benefits package including medical, dental, vision, life, paid time off, paid holidays, paid parental leave, 401K plan with employer match and annual contribution available. Dreyer's Grand Ice Cream Inc. provides equal employment opportunities for all applicants, regardless of race, religion, gender, national origin, age, disability, marital status, veteran status, or any other protected characteristic.

Posted 3 weeks ago

Fintech logo
FintechTampa, FL
Join Fintech's office in Tampa, Florida as a Quality Assurance Intern! We are seeking a passionate and driven QA (Quality Assurance) Intern who has recently completed college education and is looking to gain practical, hands-on experience in a professional software testing and quality assurance environment. This internship is ideal for recent graduates or individuals looking to transition into a career in quality assurance and provides an opportunity to gain hands-on experience in testing, automation, and quality processes, while working alongside experienced QA professionals on real-world projects. Workplace Type: Hybrid Weekly Hours: 29 hours per week Duration: 6 months, with potential for full-time employment Key Responsibilities: Assist in manual and automated testing of software applications across web, mobile, and API platforms. Work alongside senior QA engineers in the full testing lifecycle: test planning, test case design, execution, and reporting. Execute test cases and document test results, defects, and testing progress. Learn and apply automated testing frameworks including, Selenium, Cypress, Jest, and API testing tools. Participate in L3 incident management activities and support deployment testing processes. Assist with requirement readiness reviews and testing preparation activities. Debug and troubleshoot software issues, identify root causes, and work with development teams on resolution. Perform other tasks and assignments as needed to support the quality assurance team. Continuously learn and develop your skills to become a more proficient and valuable member of the QA team. Communicate effectively with team members, developers, and stakeholders regarding quality issues and testing status. Required: Bachelor's degree (completed) in Computer Science, Information Technology, Engineering, or a related field Strong interest in software quality assurance and testing. Basic understanding of software testing concepts and methodologies. Familiarity with HTML, CSS, JavaScript, and basic web application concepts. Basic understanding of SQL databases and database testing. Understanding of software development lifecycle (SDLC) and testing principles. Preferred: Exposure to automated testing tools (Selenium, Cypress, Jest, JUnit, TestNG). Experience with API testing tools (Postman, SoapUI, REST Assured). Familiarity with version control systems like Git and Azure DevOps. Basic knowledge of BDD (Behavior-Driven Development) concepts. Experience with performance testing concepts or tools (JMeter, LoadRunner). Previous project work (academic, personal, or internship) demonstrating testing skills. Soft Skills: Strong analytical and problem-solving skills with attention to detail. Good written and verbal communication skills. Ability to take initiative and work independently when needed. Collaborative mindset and openness to feedback. Critical thinking skills and ability to identify edge cases and potential issue About Fintech: Fintech, a pioneering accounts payable (AP) automation solutions provider, has dedicated nearly 35 years to automating invoice processing between retail and hospitality businesses, and their supply chain partners. Backed by leading investors TA Associates and General Atlantic, it stands as a leader in this sector. Its flagship product, PaymentSource, was first built for the alcohol industry to provide invoice payment automation between alcohol distributors and their customers across all 50 states. Today, it is utilized by over 267,000 businesses nationwide for invoice payment and collection associated with all B2B business transactions. This proven platform automates invoice payment, streamlines payment collection, and facilitates comprehensive data capture for over 1.1 million business relationships. Recognizing operational hurdles, Fintech expanded its payment capabilities to include scan-based trading/consignment selling for its vendors and retailers and built an advanced CRM tool with functionality to fortify vendor, supplier, and distributor field execution, addressing diverse profit center challenges. For more information about Fintech and its range of solutions, please visit www.fintech.com. Fintech is a Drug-Free Workplace. Fintech is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Fintech's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs and general treatment during employment. We E-Verify.

Posted 2 weeks ago

Niagara Bottling logo
Niagara BottlingElsmere, KY
At Niagara, we're looking for Team Members who want to be part of achieving our mission to provide our customers the highest quality most affordable bottled water. Consider applying here, if you want to: Work in an entrepreneurial and dynamic environment with a chance to make an impact. Develop lasting relationships with great people. Have the opportunity to build a satisfying career. We offer competitive compensation and benefits packages for our Team Members. Plant QA Manager Administers policies and programs ensuring that organizational products and processes meet established quality standards. Implement quality standards, ensures and executes compliance on every stage of the process. Essential Functions Lead the facility in all Food Safety, Packaging Quality and Product Quality related activities. Serve as the primary plant liaison within the facility for all Company Quality Assurance Initiatives, Niagara Corporate Quality and Third Party Audits Trend analytical data and develop initiatives to improve plant performance against Niagara quality measures and ensure plant compliance with company and regulatory standards Track, analyze, and lead root cause analysis for all quality and customer complaint issues within the plant Ensure compliance and record keeping for all mandated quality checks, testing, sampling and sanitation activities within the plant Monitor the microbiological program; collect and conduct microbiological analysis of product and process samples when necessary Perform water testing equipment evaluations and calibrations Conduct regular reviews of the facility's Pre-requisite Programs, GMP Compliance and Sanitation Compliance Serve as the facility Food Safety Program Coordinator, HACCP Coordinator and SQF Practitioner Manage budgeting, purchasing and inventory of QA operating supplies such as filters, chemicals and lab supplies Monitor the performance and competencies of plant QA staff and provide leadership, coaching, discipline and development as needed Assist the Research & Development team with formulation adjustments, product evaluations, and product launch activities Maintain a safe work environment and support all plant safety programs Assist with weekend and holiday coverage as needed Please note this job description is not designed to contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without prior notice. Qualifications Minimum Qualifications: 6 Years- Experience in Field or similar manufacturing environment 6 Years- Experience in Position 4 Years- Experience managing people/projects experience may include a combination of work experience and education Computer literate with proficiency in, but not limited to: Microsoft Office Applications, Visio, Oracle Business Systems, Infinity QS, etc Detail-Oriented with Excellent Oral and Written Communication Skills Knowledge of water chemistry, microbiological analysis methods, chemical analysis methods, laboratory systems and beverage sanitation practices Demonstrated ability to use data for creative problem solving, experience using statistical software packages Preferred Qualifications: 10+ Years- Experience in Field or similar manufacturing environment 10+ Years- Experience working in Position 6 Years- Experience managing people/projects experience may include a combination of work experience and education Competencies This position embodies the values of Niagara's LIFE competency model, focusing on the following key drivers of success: Lead Like an Owner Manages a safe working environment, accurately documents safety related training, and effectively communicates safety incidents Provides strategic input and oversight to departmental projects Makes data driven decisions and develops sustainable solutions Skilled in reducing costs and managing timelines while prioritizing long run impact over short term wins Makes decisions by putting overall company success first before department/individual success Leads/facilitates discussions to get positive outcomes for the customer Makes strategic decisions which prioritize the needs of the customer over departmental/individual goals InnovACT Continuously evaluates existing programs and processes, and develops new initiatives to increase efficiency and reduce waste Creates, monitors, and responds to departmental performance metrics to drive continuous improvement Communicates a clear vision, organizes resources effectively, and adjusts the strategy as needed when managing change Find a Way Demonstrates ability to think analytically and synthesize complex information Effectively delegates technical tasks to subordinates Works effectively with departments, vendors, and customers to achieve organizational success Identifies opportunities for collaboration in strategic ways Empowered to be Great Makes hiring decisions primarily based on culture fit and attitude, and secondarily based on technical expertise Engages in long term talent planning Provides opportunities for the development of all direct reports Understands, identifies, and addresses conflict within own team and between teams Education Minimum Required: Bachelor's Degree in Food Science/Technology, Chemistry, Microbiology, Engineering or other related field Preferred: Master's Degree in Food Science/Technology, Chemistry, Microbiology, Engineering or other related field Certification/License: Required: N/A Preferred: HACCP Certification Foreign Language Required: None Required Preferred: None Required Benefits https://careers.niagarawater.com/us/en/benefits *Los Angeles County applicants only Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, the California Fair Chance Act, and any other applicable local and state laws. Any employment agency, person or entity that submits a résumé into this career site or to a hiring manager does so with the understanding that the applicant's résumé will become the property of Niagara Bottling, LLC. Niagara Bottling, LLC will have the right to hire that applicant at its discretion without any fee owed to the submitting employment agency, person or entity. Employment agencies that have fee agreements with Niagara Bottling, LLC and have been engaged on a search shall submit résumé to the designated Niagara Bottling, LLC recruiter or, upon authorization, submit résumé into this career site to be eligible for placement fees. Niagara Plant Name CINCINNATI

Posted 1 week ago

Broadcom Corporation logo
Broadcom CorporationSan Jose, CA
Please Note: If you are a first time user, please create your candidate login account before you apply for a job. (Click Sign In > Create Account) If you already have a Candidate Account, please Sign-In before you apply. Job Description: Ethernet NIC product portfolio is designed for high performance computing and networking applications including AI and ML. This is driven by the growing need for high server bandwidth, highest throughput and lowest latency networks. The NIC team is involved in the development of the next generation of Ethernet NIC solutions for AI/ML and High performance computing applications. We are looking for excellent QA engineers to join the NIC product team. As a Software QA Engineer, you will be responsible for validation of the RDMA protocol features for the Ethernet NIC. You will work cross functionally with marketing, architects, silicon development and the SW teams to document, test and automate high quality software, drivers and the firmware components. Responsibilities: Define and publish test plans for the RDMA protocol features for the Ethernet NIC products. Work closely with the architecture teams, silicon design teams and other software / firmware teams to design and execute performance and scale testing. Hands-on in test planning, automation and validation of RDMA protocol features to deliver high quality, high performance and functionally excellent products. Work closely with the SW team for a better test coverage and execution in the product release cycle. Work closely with the customer support engineers on any customer field issues and provide timely help for issue reproductions and closure. Requirements: BS/MS in Computer Science, Electronics & Communications or equivalent with minimum 12+ years of experience. Significant experience in RDMA protocol, QoS, Packet Classifications, Linux Systems programming, Linux kernel, Linux Network Drivers, Linux Kernel Networking, Virtual Switching and Data center Networking, and firmware development and testing. A good understanding of the RDMA protocol is a must have. Hands-on experience with RDMA is highly desired. Experience in writing test scripts to verify NIC behavior is highly desired. Excellent programming skills in Python is a must. Strong analytical, problem solving and debugging skills in a combined software and hardware environments. Excellent written and verbal communication skills, ability to efficiently collaborate with multiple teams across geographically diverse areas. Additional Job Description: Compensation and Benefits The annual base salary range for this position is $141,300 - $226,000 This position is also eligible for a discretionary annual bonus in accordance with relevant plan documents, and equity in accordance with equity plan documents and equity award agreements. Broadcom offers a competitive and comprehensive benefits package: Medical, dental and vision plans, 401(K) participation including company matching, Employee Stock Purchase Program (ESPP), Employee Assistance Program (EAP), company paid holidays, paid sick leave and vacation time. The company follows all applicable laws for Paid Family Leave and other leaves of absence. Broadcom is proud to be an equal opportunity employer. We will consider qualified applicants without regard to race, color, creed, religion, sex, sexual orientation, national origin, citizenship, disability status, medical condition, pregnancy, protected veteran status or any other characteristic protected by federal, state, or local law. We will also consider qualified applicants with arrest and conviction records consistent with local law. If you are located outside USA, please be sure to fill out a home address as this will be used for future correspondence.

Posted 30+ days ago

Seek Now logo
Seek NowAtlanta, GA
Why Join Us? We're a high-growth, profitable tech company reshaping how the insurance industry handles property claims. While this space isn't known for being "high-tech," we're changing that narrative-building solutions that were once thought impossible. As a Quality Engineer, you'll play a pivotal role in ensuring our products not only work flawlessly but set the gold standard for reliability in the industry. What You'll Do Design & Lead- Build evolving test strategies for new features and functionality, ensuring quality is baked in from day one. Engineer Confidence- Develop and maintain a robust library of test approaches across web and mobile, so our teams can move fast without breaking things. Test Smart- Execute both manual and automated testing, leveraging the right tools to keep our suite resilient. Be the Product Expert- Dive deep into our offerings, collaborate with Product Support & Development, and track down root causes with precision. Raise the Bar- Champion quality practices across engineering, helping teammates ship with confidence. What You Bring QA Mindset- A strong grasp of modern testing methodologies, test design thinking, and the art of finding what others might miss. Web & Mobile Expertise- Hands-on experience testing modern web apps and hybrid mobile applications. Collaborator at Heart- You thrive on helping engineers succeed, quickly analyzing and fixing issues when things inevitably break. Problem-Solver- Strong critical thinking and troubleshooting skills that cut through complexity. Bonus Points If You Have Experience automating tests for front-end, back-end, or mobile apps using tools like Selenium, Cypress, Postman, Playwright, or others you've wielded successfully. Why You'll Love It Here Impact from Day One- Your work ensures our products deliver on the promise of reliability in a space that desperately needs it. Fast Growth, Big Opportunities- As we scale, so do your opportunities-whether it's leadership, specialization, or new tech domains. Collaborative Culture- Work with smart, humble teammates who prioritize results over ego. Autonomy & Trust- We give you the freedom to solve problems your way. EEO Statement: Seek Now is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. Seek Now does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Posted 2 weeks ago

Perplexity AI logo
Perplexity AISan Francisco, CA
Perplexity is an AI-powered answer engine founded in December 2022 and growing rapidly as one of the world's leading AI platforms. Perplexity has raised over $1B in venture investment from some of the world's most visionary and successful leaders, including Elad Gil, Daniel Gross, Jeff Bezos, Accel, IVP, NEA, NVIDIA, Samsung, and many more. Our objective is to build accurate, trustworthy AI that powers decision-making for people and assistive AI wherever decisions are being made. Throughout human history, change and innovation have always been driven by curious people. Today, curious people use Perplexity to answer more than 780 million queries every month-a number that's growing rapidly for one simple reason: everyone can be curious. Perplexity is looking for a Quality Assurance Tester to join our small team revolutionizing the way people search and interact with the internet. Your passion and diligence will be critical to ensure a high quality product. You will work closely with product management, engineering and support teams. The ideal candidate should have strong communication and writing skills, an eagerness to learn, and attention to detail. Responsibilities Understand and analyze the existing product as well as new features Detect bugs and UI issues on a variety of devices, browsers, and operating systems Work with product management and engineering to debug and resolve issues Develop, document, and execute test plans, test cases, and test scripts Qualifications Diligent approach to testing and QA Organization and communication skills Understanding of AI products, including prompting Ability to learn new software tools quickly Understanding of user needs and situations 4+ years of industry experience Nice to have Experience with Playwright and Typescript Experience leading projects or teams The cash compensation range for this role is $90,000 - $130,000 Final offer amounts are determined by multiple factors, including, experience and expertise, and may vary from the amounts listed above. Equity: In addition to the base salary, equity may be part of the total compensation package. Benefits: Comprehensive health, dental, and vision insurance for you and your dependents. Includes a 401(k) plan.

Posted 30+ days ago

I logo
INCOG BioPharmaFishers, IN
This role is a great opportunity to work with Quality Control personnel but within the realm of Quality Assurance. The candidate will have the opportunity to learn about the equipment used to perform testing as well as the different methods for performing each test. The ideal candidate will be able to communicate with the other data reviewers to ensure adherence to quality standards. The Quality Assurance Technical Services (QATS) Specialist is responsible for reviewing and approving Quality Control (QC) and Incoming Quality Control (IQC) documentation. This documentation includes data from QC Microbiology, Chemistry, IQC and Method Transfer. The QATS Technical Services Specialist will work in coordination with Quality Control Technical Services (QCTS) to perform periodic walkthroughs of the Quality Control laboratories to ensure good laboratory practices are followed and the areas meet regulatory inspection readiness. Essential Job Functions: Perform laboratory data review processes for incoming materials, in-process, finished product, and stability testing from QC Chemistry, Microbiology, IQC and Method Transfer. Partner with Quality Control in the data analysis and data review process. Establish an ongoing state of readiness in the exercising of rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions. In coordination with QA and QC management, use knowledge of quality principles, cGMPs, and regulatory standards to maintain a state of constant inspection-readiness in the QC laboratories. Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, etc.) to ensure data integrity for all Quality Assurance and Quality Control site policies, procedures, and testing records. Use technical skills and applied statistics to analyze and identify sources of variability and error in QC processes. Special Job Requirements: Bachelor's Degree required in Science (Chemistry, Biology, Microbiology or Biochemistry). Minimum of 3 years' experience of GMP biopharma industry experience, with at least 1 year experience with isolator-based aseptic manufacturing environments required. Experience as a technical data reviewer in a GMP regulated industry. High level of understanding and oversight of Quality Control testing processes in both QC Chemistry and QC Microbiology for aseptic manufacturing. Exemplifies excellent interpersonal skills and can develop productive working relationships with colleagues, customers, suppliers, and partners. Demonstrated ability to influence positive outcomes without direct reporting authority. Demonstrates excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. Commits to a culture of quality with skills including attention to detail, on time delivery, and efficiency. Upholds customer-centric mindset. Additional Preferences: Thrives in a team environment but can work autonomously with strong self-management and organizational skills. Ability to handle a variety of tasks in a timely fashion. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

Posted 30+ days ago

Dreyer's Grand Ice Cream logo
Dreyer's Grand Ice CreamFort Wayne, IN
Role and Activity Developing high quality standards and ownership across value chain Lead by example to carry out all duties and specific responsibilities operational Quality and Food Safety Policies and Procedures. Promote the culture change towards behavioral quality improvements Provide expertise to operations for promoting and executing quality to provide customers with exceptional ice cream experience Direct and supervise the quality specialists and quality techs to ensure daily activities promote production of quality ice cream products on the lines Partner with operations management on key quality checks to be completed by line operators. Checks need to be evaluated periodically to ensure they are in line with hold and complaint data. Manage quality hold program and partner with operations to complete lesson learnt (root cause) and implement corrective action identified. Provide trend data to demonstrate effectiveness of corrective action implementation. Provide leadership on customer complaint reduction by partnering with operations on strategies to reduce complaints by using complaint trend data to prioritize actions. Oversee and provide leadership on the net content to establish facility specific rules to ensure compliance to both volume and weight targets Provide support to TAG on new product launches or formulation when requested. Identify, communicate to plant operations and apply "Best Practices" within the facility or from the broader network. Drive improvements and monitor Quality Metrics/KPI's at the facility Represent The Froneri Way of working through the behaviors and characteristics in our Operating Model and Core Values Challenge all departments on quality and food safety related Provide support to GMP and HACCP, FSMA FSP compliance through out the facility, by coaching operators when on the floor and promoting minimal water use during production. Ensure compliance to internal and external audits i.e. FSSC 22000/Market audits Provide support to local, State and Federal agencies when requested by local quality management Drive Monthly reviews of KPI's and contribute towards meeting the yearly business goals for the facility. Monitor and assess performance of the quality systems, report their effectiveness to management and implement actions for improvement Measurable Outcomes CPMU reduction Respect of GMP and distribution of the "lesson learnt " Reduction of pallets on holds Reduction of food safety incidents Being on the shop floor making ice-cream Drive improvements from benchmarking improvements Levels of responsibility Deploy QA standards Achieve QA targets defined at market level (CPMU, RFT, CRQS…) Hold program Net Content execution BEHAVIORS AND CORE VALUES: Must consistently showcase the desired behaviors that represent our Core Values. We Take Ownership Stay committed to responsibilities from start to finish Make sound decisions and get into the right level of detail Apply resources to initiatives that add growth, improve efficiencies, or reduce waste We Do What Is Right Choose transparency over convenience, even if it means difficult conversations Set clear roles and responsibilities, enabling everyone to exercise appropriate initiative and judgment Speak up when you see something that does not align to our values and policies We Seek to Improve Strive to continuously improve and innovate to exceed expectations Value feedback from others and encourage open dialogue to understand how we can improve Learn from both successes and failures We Are Better Together Ensure decisions are based on what's best for the whole business Practice inclusion by seeking diverse perspectives Treat everyone with fairness and respect WORK ENVIRONEMENT In this position, the employee will regularly work with and around others; in a wet and/or humid environment; in areas of high noise level; and around mechanical, electrical, and pressurized equipment. The work is fast paced. The position involves frequent exposure to nuts and other potential allergens. The pay scale for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. At Dreyer's Grand Ice Cream, it is not typical for an individual to be hired at or near the top of the range for their role, and compensation decisions are dependent on the facts and circumstances of each case. The pay range for prospective employees in this role is between $68,0000-$80,000 a year. Dreyer's Grand Ice Cream Inc. provides equal employment opportunities for all applicants, regardless of race, religion, gender, national origin, age, disability, marital status, veteran status, or any other protected characteristic.

Posted 30+ days ago

Lonza, Inc. logo
Lonza, Inc.Portsmouth, NH
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Key responsibilities: Rotate daily through GMP operational areas to review GMP documentation and observe GMP work habits. Authorize the placement and removal of Quality Tag Outs. Respond to QA Hotline calls to support GMP operations. Provide GMP mentoring to Manufacturing, QC, Engineering/Facilities, and MSAT. Document all items within QAOTF shift notes and provide follow-up for other shifts as needed. Represent QA in meetings or on project teams. Identify standard methodologies and supply to the continuous improvement of QA processes. Key requirements: Excellent written and verbal communication skills. Meticulous focus on detail and excellent investigation, problem-solving, and coordination abilities. Proven track record to work effectively with people, communicate negative information, and acquire positive results. Facilitate positive interdepartmental interactions with a diverse group of people, communicate needs and suggestions clearly, and listen attentively. Familiarity with SAP, TrackWise, DMS, and LIMS systems is an advantage. Flexibility to adapt to changing tasks while maintaining efficiency. Keep project leads and team members advised of the status of assigned work. Strong, diligent teammate with a positive proactive approach to drive projects/tasks to completion. Proficient in Microsoft Office applications. Effective negotiation skills to resolve differing perspectives. Accurately prioritize tasks and lead time optimally. Education: Bachelor's Degree required. 3-5 years proven experience in a related field. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Posted 2 weeks ago

L logo
Lilt Inc.Washington, MN
About LILT AI is changing how the world communicates - and LILT is leading that transformation. We're on a mission to make the world's information accessible to everyone, regardless of the language they speak. We use cutting-edge AI, machine translation, and human-in-the-loop expertise to translate content faster, more accurately, and more cost-effectively without compromising on brand, voice, or quality. At LILT, we empower our teammates with leading tools, global collaboration, and growth opportunities to do their best work. Our company virtues-Work together, win together; Find a way or make one; Quicker than they expect; Quality is Job 1-guide everything we do. We are trusted by Intel Corporation, Canva, the United States Department of Defense, the United States Air Force, ASICS, and hundreds of global Enterprises. Backed by Sequoia, Intel Capital, and Redpoint, we're building a category-defining company in a $50B+ global translation market being redefined by AI. LILT in the News We were named to The Software Report's fifth annual list of Software Companies! Click here to learn more and see the full list. LILT listed on the Inc. 5000 List for the first time. Check out all our news on our website. About Us LILT is the leading AI solution for enterprise translations. Our stack made up of our Contextual AI Engine, Connector APIs, and Human Adaptive Feedback enables global organizations to adopt a true AI translation strategy, focusing on business outcomes instead of outputs. With LILT, innovative, category-defining organizations like Intel, ASICS, WalkMe, and Canva are using AI technology to deliver multilingual, digital customer experiences at scale. While our core AI technology might share similarities with ChatGPT and Google Translate, it's what we do with it that makes LILT truly revolutionary. Our patented Contextual AI Engine goes beyond basic translations, understanding the nuance of our customer's content and target audience to deliver hyper-accurate, business-focused results. Our connector-first approach seamlessly integrates with our customer's existing workflows, and our human-adapted feedback loop ensures continuous improvement, making LILT a constantly evolving AI partner for your global ambitions. The Engineering Team at LILT LILT is a high-performance, large-scale language translation system. We invest in and prioritize workflow (i.e., usability and interface design) and backend AI systems. Since the translation workforce is distributed worldwide, there are interesting cloud engineering problems to solve. We have a strong preference for building our own backend technology, so you'll be implementing and working with the latest natural language processing (NLP) techniques and ideas. Where You'll Work This position is based out of our Washington D.C., Boston, or New York area locations where you will start as fully remote and go into the office once a location is determined and will be expected to work in the office in a hybrid capacity. Get the best of both worlds at LILT! Dive into dynamic in-office energy 2-3 days a week, sparking creativity and forging bonds with your awesome team. Then, seamlessly shift gears and crush your to-do list from the comfort of your home base for the rest of the week. It's the perfect harmony of productivity and personal freedom. Want a peek inside? Visit our Careers page! Authorization to work in the US is a precondition of employment. Key Responsibilities: Design, develop, and maintain automated test scripts for the LILT platform, focusing on various aspects like API testing, UI testing, and performance testing. Collaborate with development and QA teams. You will work closely with developers and manual testers to understand requirements and identify areas for automation. Execute automated tests, analyze results, and generate comprehensive reports. Triage and resolve automated test failures. Perform manual testing of new features and functionality, including exploratory testing and regression testing. Document and maintain a database of known test cases for all application features. Contribute to and help lead our software release process. Communicate test results and findings clearly and concisely, reporting test results and any issues found to the relevant teams. Skills and Experience: A solid understanding of software testing principles and methodologies is essential. An ability to create effective test plans and test cases. Proficiency in JavaScript/Typescript, as you'll be writing and maintaining test cases primarily built on Playwright, Cypress and JEST frameworks. An understanding and proficiency with various automation frameworks is crucial. Playwright, Cypress and/or JEST preferred. Experience with Git and Github. Proficiency with Jenkins or other Continuous Integration and Continuous Delivery tools. Understanding of API testing concepts and API testing tools like Postman. Experience with load or performance testing with tools like Grafana K6. Basic understanding of an RDBMS and SQL. Clear and concise communication is essential for collaborating with developers, product managers, and other stakeholders. Our Story Our founders, Spence and John met at Google working on Google Translate. As researchers at Stanford and Berkeley, they both worked on language technology to make information accessible to everyone. They were amazed to learn that Google Translate wasn't used for enterprise products and services inside the company and left to start a new company to address this need - LILT. At its core, LILT has always been a machine learning company since its incorporation on March 6, 2015. At the time, machine translation didn't meet the quality standard for enterprise translations, so LILT assembled a cutting-edge research team tasked with closing that gap. While meeting customer demand for translation services, LILT has prioritized investments in Large Language Models, believing that this foundation was imperative to the future of enterprise translation. Benefits: Compensation: At market salary, meaningful equity, 401(k) matching, and flexible time off plus company holidays Medical Benefits: Employees receive coverage of medical, dental, and vision insurance, plus FSA/DFSA, HSA, and Commuter benefits. In addition, LILT pays for basic life insurance, short-term disability, and long-term disability Paid parental leave is provided after 6 months. Monthly lifestyle benefit stipend via the Fringe platform to allow employees to customize benefits to their lifestyle Information collected and processed as part of your application process, including any job applications you choose to submit, is subject to LILT's Privacy Policy at https://lilt.com/legal/privacy . LILT is an equal opportunity employer. We extend equal opportunity to all individuals without regard to an individual's race, religion, color, national origin, ancestry, sex, sexual orientation, gender identity, age, physical or mental disability, medical condition, genetic characteristics, veteran or marital status, pregnancy, or any other classification protected by applicable local, state or federal laws. We are committed to the principles of fair employment and the elimination of all discriminatory practices. Our Story Our founders, Spence and John met at Google working on Google Translate. As researchers at Stanford and Berkeley, they both worked on language technology to make information accessible to everyone. While together at Google, they were amazed to learn that Google Translate wasn't used for enterprise products and services inside the company.The quality just wasn't there. So they set out to build something better. LILT was born. LILT has been a machine learning company since its founding in 2015. At the time, machine translation didn't meet the quality standard for enterprise translations, so LILT assembled a cutting-edge research team tasked with closing that gap. While meeting customer demand for translation services, LILT has prioritized investments in Large Language Models, human-in-the-loop systems, and now agentic AI. With AI innovation accelerating and enterprise demand growing, the next phase of LILT's journey is just beginning. Our Tech What sets our platform apart: Brand-aware AI that learns your voice, tone, and terminology to ensure every translation is accurate and consistent Agentic AI workflows that automate the entire translation process from content ingestion to quality review to publishing 100+ native integrations with systems like Adobe Experience Manager, Webflow, Salesforce, GitHub, and Google Drive to simplify content translation Human-in-the-loop reviews via our global network of professional linguists, for high-impact content that requires expert review LILT in the News Featured in The Software Report's Top 100 Software Companies! LILT makes it onto the Inc. 5000 List. LILT's continues to be an intellectual powerhouse, holding numerous patents that help power the most efficient and sophisticated AI and language models in the industry. Check out all our news on our website. Information collected and processed as part of your application process, including any job applications you choose to submit, is subject to LILT's Privacy Policy at https://lilt.com/legal/privacy . At LILT, we are committed to a fair, inclusive, and transparent hiring process. As part of our recruitment efforts, we may use artificial intelligence (AI) and automated tools to assist in the evaluation of applications, including résumé screening, assessment scoring, and interview analysis. These tools are designed to support human decision-making and help us identify qualified candidates efficiently and objectively. All final hiring decisions are made by people. If you have any concerns, require accommodations, or would like to opt-out of the use of AI in our hiring process, please let us know at recruiting@lilt.com. LILT is an equal opportunity employer. We extend equal opportunity to all individuals without regard to an individual's race, religion, color, national origin, ancestry, sex, sexual orientation, gender identity, age, physical or mental disability, medical condition, genetic characteristics, veteran or marital status, pregnancy, or any other classification protected by applicable local, state or federal laws. We are committed to the principles of fair employment and the elimination of all discriminatory practices.

Posted 30+ days ago

Harris Companies logo
Harris CompaniesSouth Bend, IN
he purpose of your role as a QA + QC Manager As a QA + QC Manager, you will manage and implement various quality assurance programs in the field. This position ensures that all external and internal requirements are met before product is turned over to the customer. This is an on-site role based out a job site in New Carlisle, Indiana. Documentation and Reporting Review and assist in the creation of project QC documents and forms. Review and update standard operating procedures or quality assurance manuals. Identify, document, track, and ensure the repair or replacement of all non-conforming work in their designated areas of responsibility. May assist with producing reports regarding nonconformance of products or processes, daily production quality, root cause analyses, or quality trends. Review quality documentation necessary for regulatory submissions and inspections. Communicate quality control information to all relevant organizational departments, outside vendors, or contractors. May instruct staff in quality control and analytical procedures. Participate in the development of specifications to ensure quality control. Review quality documentation necessary for regulatory submissions and inspections. Instruct vendors or contractors on quality guidelines, testing procedures, or ways to eliminate deficiencies. Make customer site visits. Quality Controls Procedures and Testing Create and implement inspection and testing criteria or procedures. Confer with other departments as needed to define client requirements and expectations. Coordinate the testing and inspection activities of any independent testing and inspection agencies to ensure that all necessary testing and inspections are properly and consistently performed. Participate in all applicable inspections and tests. Also perform follow-up inspections and examinations as necessary to ensure continued compliance with the requirements of the contract documents. Help identify and mitigate items that may arise from providing and installation non-basis of design equipment. Analyze quality control test results and provide feedback and interpretation to production management or staff. Monitor performance of quality control systems to ensure effectiveness and efficiency. Coordinate the selection and implementation of quality control equipment. Quality Assurance Weld mapping/tracking Documentation of leak testing Obtaining the proper sign offs from the client Verification of materials meeting the requirements Completing job turnover packages Reviewing client engineering standards Reference ASME codes for compliance Quality Control Inspection of completed welds In-process examination of construction activities-Civil, Structural, Mechanical, Piping Witness and inspection of pressure tests Punch of complete systems prior to turnover to the client Working with foreman/general foreman to identify issues needing correction in the field Preparing requests for the site NDE services Reviewing and acceptance of inspection reports Testing welders on-site for qualification & Continuity Management. Inspection of bolt up joints for proper gaskets and correct bolt up. Witness and verification of Torqued components. What we're looking for in you Bachelor's degree in Engineering preferred. 5+ years Prior experience in quality control or quality assurance 5+ years and proficient with Microsoft Office 5+ years and in depth understanding of quality control procedures and relevant legal standards Your life at Harris As one of the country's leading mechanical contractors, Harris offers you the best of both worlds: the stability, resources and opportunities of a national company, and the team culture, creative spirit and customer loyalty of a local business. If you thrive on variety and new challenges, we want to meet you! From stadiums to manufacturing facilities, power plants to hospitals, concert halls to classrooms, we handle projects of all sizes and complexity from multiple regional locations across the country. Harris Benefits + Compensation Medical, dental, vision, and life insurance 401K with company match Vacation time, sick time, and paid holidays Paid Parental leave Short-Term Incentive Plan Visit our Careers Page for additional benefit details: https://www.harriscompany.com/careers/employee-benefits-at-a-glance Pay Range: $95,350 - $143,024 per year. The actual salary offer will vary by candidate based on a wide range of factors such as specific skills, qualifications, experience.

Posted 30+ days ago

Técnico Corporation logo
Técnico CorporationChesapeake, VA
Position Summary Oversees and evaluates the daily responsibilities of Quality Inspectors to ensure adherence to the Quality Management System. Guarantees consistent quality production through process verification and documentation review. Engages with cross-functional teams to uphold quality standards. Develops and maintains quality evaluation and control systems and protocols to align with customer specifications and requirements. Essential Duties and Responsibilities Ensures adherence to the organization's Quality Management System (QMS), production standards, and customer specifications. Oversees and orchestrates the operations and procedures of the Quality Assurance department, as well as the daily activities and responsibilities of direct reports. Oversees Quality Assurance team members ensuring strong performance and operational success. Administers performance reviews, coaching, and development activities as necessary. Manages the internal audit program to ensure adherence to company policies and procedures. Engages in external audits to assess the suitability of suppliers for utilization. Provides employee training and technical leadership. Manages the organization's corrective action program, encompassing both Corrective Action and Preventative Action requests associated with production activities, to ensure adherence to established policies, procedures, and work instructions. Oversees the non-destructive testing (NDT) program, ensuring compliance with inspector certifications, conducting surveillance of ongoing welding processes, and reviewing weld packages for quality assurance. Manages the calibration processes and oversees programs related to non-conforming materials. Facilitates, documents, and ensures compliance with training programs as required by the Quality Management System (QMS). Provide health and safety leadership and direction to Division, Department, Branch Offices and Project Managers. Serve as the corporate environmental, health and safety subject matter expert with clients, regulators, and Company staff working on projects or designing proposal responses. Manage environmental, health and safety resources and related departmental budgets. Manage corporate environmental, health and safety staff. Consistently demonstrates punctuality, adheres to management directives, fosters positive collaboration with colleagues, complies with organizational policies and procedures, and actively contributes to achieving team and company goals with initiative and commitment. Other duties as assigned, requested or needed. Position Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. Education and Experience: Bachelor's degree or equivalent education and 5 years' experience (military/marine or ship repair industry preferred). Knowledge, Skills and Abilities: Working knowledge of shipyard, maritime, preferred. Possessing a comprehensive understanding of Navy ship repair processes and procedures is highly desirable. Knowledge of NAVSEA standard items, the Joint Fleet Maintenance Manual, NAVSHIPS Technical Manuals, Department of Defense standards, and military specifications is highly advantageous. Ability to work at a high level of accuracy and attention to detail. Ability and tolerance to meet due dates and deadlines and/or time constraints. Ability to evaluate and analyze departmental and industry trends. Knowledge of and ability to utilize Microsoft office applications. Ability to resolve complaints and negotiate with others.

Posted 30+ days ago

U logo
United Therapeutics CorporationMorrisville, PA
California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are Are you passionate about creating processes to support combination product quality control testing? In this role you'll be part of a 'greenfield' project helping stand up a new Quality Assurance team. You'll be counted on to think outside of the box, troubleshoot, and make fast but accurate decisions. The QA Manager, Analytical Services will ensure the timely and accurate Quality oversight for QC chemistry and microbiological testing of materials and UTC combination products while maintaining and ensuring all quality and compliance requirements are satisfied. This role will provide oversight and guidance on day-to-day activities of scientists in the Combination Products QC laboratory, defining and proposing solutions for technical problems within their scope of work, and serve as an internal technical expert for Quality Assurance activities. Provide QA management and oversight of QC laboratory operations for all defined QC testing activities including incoming materials, in-process samples, and drug substance and drug product testing, including oversight of assigned product development (R&D) testing and contract laboratory testing Develop and lead implementation of the quality assurance procedures and activities to ensure that the company's processes and products are in compliance Oversee departmental training including generation, review, and approval of training plans, delivery of hands-on training as needed, monitoring for departmental training compliance, development of new training requirements as needed, and retraining needs and frequencies Lead and support QA continuous improvement initiatives related to compliance/quality requirements, introduction of new products/processes, and QC operations, including evaluating emerging technologies, new instrumentation, and alternate methodologies and recommending implementation, as appropriate Conduct or provide management oversight of investigations and deviations related to testing or other QC processes and perform QA approval Review and approve SOPs, test methods, and product specifications to ensure alignment with regulatory requirements, internal quality standards, and industry best practices Review and approve laboratory instrumentation qualification and validation protocols, test method transfer protocols, and other testing protocols, including testing to support process validations, process or material changes, development product stability, etc. Review and approve Certificates of Analysis (CoAs) to ensure accuracy, completeness, and compliance with regulatory standards Ensure laboratory metrics are reported in an accurate and timely manner and that those metrics are meeting established performance standards. Actively address any metrics that are indicating performance at an unacceptable level with appropriate departmental managers. May direct and manage a team to include responsibility for goal setting, performance evaluations, coaching, mentoring and career development For this role you will need Minimum Requirements Bachelor's Degree in chemistry or related scientific field 8+ years of experience in a GMP pharmaceutical QC laboratory with a Bachelor's Degree or 6+ years of experience in a GMP pharmaceutical QC laboratory with a Master's Degree 2+ years of experience providing oversight or technical leadership of laboratory operations in a GMP Quality Assurance setting Experience scheduling/prioritizing all assigned QA activities related to commercial manufacturing operations including incoming sampling and testing, in-process testing, finished drug substance or drug product testing, and registration and annual stability programs Knowledgeable of FDA cGMP requirements and familiar with USP testing requirements for pharmaceutical and combination products Excellent computer application skills required with expertise in Microsoft Suite applications as well as chromatography application programs and LIMS systems Hands-on laboratory instrumentation experience and review of HPLC, GC, UV/VIS, and FTIR data Experience incorporating project testing activities for remediation activities, new project/product support (development, validation, etc.), implementation/maintenance of laboratory systems such as LIMS, and training QA performance into existing schedules to ensure departments needs are addressed Experience and expertise with investigative techniques including OOS methodology, root cause analysis, statistical sampling and shelf life projection tools, etc. Technical and leadership experience in GMP, combination products Quality Control laboratory Experience reviewing new test methods, test method transfer protocols, and qualification of laboratory equipment protocols (IQ, OQ, PQ) Preferred Qualifications Master's Degree in chemistry or related scientific field Experience resolving problems with contract testing laboratories to meet commercial product timelines Experience with resource allocation for QA oversight of a commercial QC laboratory Job Location United Therapeutics requires this candidate to be 100% on-site at our Durham, NC location. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.

Posted 1 week ago

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Legend Biotech CorpSomerset, NJ
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Sr. Manager of GLP QA as part of the Regulatory Affairs team based in Somerset, NJ. Role Overview The incumbent/appointee will be responsible for ensuring that the relevant nonclinical studies are performed in compliance with GLP regulations and Health Authorities' guidance/principles. He/she will maintain a compliant quality system to meet these requirements, and will be responsible for the overall (GLP) quality oversight of studies, from the assessment of external vendors via audits to their onboarding. The appointee will oversee the overall laboratory processes by reviewing and/or supporting the development of SOPs, and supporting the bioanalytical assays that are required for the GLP or CGLP studies. She/he may be involved in overseeing the work performed by external contract research organizations (CROs) and/or consultants. It is expected that the appointee will have a broad knowledge of GCP/ICH guidelines in order to support cross-functional teams and provide input in GCP/GLP processes; in fact, he/she will partner with the study teams in order to maintain and/or reinforce a 'quality culture', thus contributing to Legend Biotech's inspection-readiness goal. The appointee is expected to be local (Somerset, NJ) and be on a hybrid work schedule (i.e., 2-3 days working at the Somerset, NJ, site.) The incumbent will report to the Sr. Director of Clinical Quality Assurance. Key Responsibilities Support the GLP quality compliance systems, via established policies and procedures for the GLP QA function. Manage GLP quality systems including all implementation and maintenance of procedures and standards. Perform audits and other reviews when necessary or required to ensure compliance. Support the process of GCP/GLP deviations from study protocols or standard operating procedures. Support internal and external GLP study audits and general laboratory compliance audits to ensure that laboratories, internal and external are adhering to all quality protocols and regulations. Collaborate with the GLP's relevant functions in reviewing relevant data for nonclinical and clinical studies to verity data integrity and to ensure work was performed according to protocols and complied with all relevant regulations. Provide quality oversight of contract or internal testing facilities to ensure adherence to all regulations, standard procedures and protocols. Alert the appropriate level of management with any non-compliance issues, ensure all corrective actions take place and elevate concerns when necessary. Support the development of agenda items for Early Development (EDD) team meetings to provide input and quality perspectives Provide input in the development of GLP related SOPs, and support cross-functional teams in the development of "Quality" related documentation (e.g., SOPs, training modules), and other documents as assigned. Communicate activities and feedback to core Quality management team to allow other team members to identify any issues or action items that need addressing. Contribute to GLP audits/inspections and coordinate the review of responses to regulatory agency questions resulting from these inspections, and/or from external/internal audits Requirements Bachelor's degree in biology, biochemistry, or the life sciences Must be able to communicate effectively in English A minimum of 3 years (for Sr. Manager) or 1 year (for Manager level) of related industry experience in Quality 3 years of experience in working and/or overseeing GLP Quality in laboratories testing biologics Experience performing audits of GLP testing labs is a plus Experience with participation in and hosting regulatory audits is a plus Experience working with CROs, vendors, and relationship management Experience in auditing activities Ability and desire to work well with diverse employees and customers in a cooperative and supportive manner. Must be a team player with good interpersonal skills, a forward thinker, always looking for pragmatic solutions that highlight 'quality' while being resource-efficient Strong project management skills Ability to articulate QA-GLP perspective and the status of QA-related activities at cross-functional meetings Working knowledge of relevant FDA, ICH GCP guidelines, and GCP, GLP related regulations Results driven with demonstrated successful outcomes #Li-JR1 #Li-Hybrid The anticipated base pay range is: $142,146-$186,567 USD Benefits: We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.

Posted 30+ days ago

Eli Lilly and Company logo
Eli Lilly and CompanyConcord, CA
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. The Lead Technician QA is responsible for providing QA oversight to GMP operations. The role will provide QA support of the start-up and qualification of the Concord site. The QA Floor Support Specialist will demonstrate teamwork by collaborating cross functionally with various levels of the organization. As the project progresses, this role will transition to supporting and escalating issues from manufacturing to the site-based process team for one of the following manufacturing areas: Formulation and Equipment Preparation Processes Parenteral Filling (Pre-Filled Syringes) Automated and Semi-automated Visual Inspection Responsibilities: Support on-the-floor manufacturing activities with routine presence in the assigned manufacturing area. Follow good documentation practices and compliance with site procedures. Review and approve GMP documentation such as electronic batch records, logbooks, etc. Support creation of Standard Operating Procedures and associated Forms, Tools and Training. Troubleshoot and provide support to resolve equipment alarms and other issues in quality systems such as Trackwise and MES. Maintain open communications between cross functional teams and area leadership. Support the execution of inspection readiness activities including support of site self-inspections. Support project initiatives needed for the project and Quality function. Communicate any compliance issues associated with the project or site to Quality Management. Evaluate potential product quality impact for any GMP-related incident and support the investigation and assist with safety investigations. Basic Requirements: High School diploma or equivalent 2 to 3 years of experience and expertise performing quality support independently in manufacturing environments (food, tobacco, but pharmaceutical preferred) Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B paths or at R1 Level. Additional Preferences: Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills Strong attention to detail Ability to work independently with minimal supervision Proficiency with computer systems including Trackwise, MES, Microsoft Programs Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals Associates or Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study, preferred Previous experience with GMP manufacturing equipment prep, formulation, filling, and visual inspection Previous experience with Manufacturing Execution Systems (MES) or electronic batch records Previous technical writing experience Technical aptitude and ability to train and mentor other team members Additional Information: Ability to work 12 hour shifts onsite on a rotating 2-2-3 schedule (not eligible for remote work) Overtime and off-shift support may be required May be required to respond to operational issues outside of core business hours and days May be subject to post-offer physical and vision exam Job is exposed to repetitive movements such as: Walking, Sitting, Bending, Twisting Must have ability to lift 30lbs Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $28.12 - $41.25 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Posted 6 days ago

Expanse Electrical logo
Expanse ElectricalWilliston, ND
Expanse seeks a highly specialized and experienced QC/QA & Controls System Specialist to serve as the definitive technical authority on all control panel products. This is a critical, hands-on leadership role for which only those with extensive, demonstrable qualifications should apply. The successful candidate will be solely responsible for the rigorous inspection, validation, and certification of industrial control panels to ensure absolute compliance with all regulatory and safety standards, including UL508A, UL698A, and UL891. We require proven, deep technical expertise in low-voltage (480VAC) systems and advanced, verifiable proficiency in PLC programming across all major industrial brands. In return for this high level of expertise, Expanse offers a highly competitive compensation package commensurate with experience. This specialist will be instrumental in implementing and enforcing a robust Quality Management System (QMS) and championing continuous improvement initiatives through proven Lean methodologies. Organizational Relationships: The position reports to the Director of Manufacturing and must maintain a sound working relationship with the customer(s), company management, supervisors, business management, team leads, technicians, administration, and vendors. Technical Responsibilities: Low Voltage System Validation: Conduct expert-level inspection, testing, and troubleshooting of all control panel wiring, components, and circuitry. A specialized focus and documented experience in ensuring safety and performance for 480VAC power systems is required. Mandatory Advanced Controls Functional Testing: Perform in-depth validation and debugging of complex PLC programs and control logic for all major brands, including but not limited to Allen-Bradley and IDEC, ensuring all systems meet or exceed precise specifications. Mandatory Regulatory Compliance and Certification: Ensure and document full adherence to all critical industry standards, including UL508A, UL698A, UL891, and Hazardous Location (HazLoc) codes. Ensure all products are certified for market release without exception. Mandatory Technical Documentation Management: Assume full ownership of the quality assurance documentation system. This includes developing and rigorously maintaining procedures for continual feedback to the engineering team on print red-lines and utilizing high proficiency in Microsoft Excel for advanced data analysis and reporting. Mandatory Systems Engineering Feedback: As a cornerstone of the QMS, inspect all panels against blueprints and specifications. Develop, maintain, and enforce a procedure for providing documented and continuous technical feedback to the engineering team to foster continuous improvement in design. Leadership and Strategic Responsibilities: QMS Champion: Drive the development, documentation, and implementation of a robust QMS, ensuring it meets or exceeds all industry standards. Continuous Improvement Leader: Champion a LEAN culture, educating the team on the eight wastes and driving their reduction or elimination. Lead and enforce 3S (sort, sweep, standardize) endeavors in the quality area and participate in initiatives across the shop. Develop a quality program that provides daily, metric-driven feedback to the production team. Gather data to analyze and report rework losses and lead quality-focused special projects. Team Development and Mentorship: Lead, mentor, and develop quality technician(s), assigning and delegating tasks to execute on the strategic vision. Develop and implement training programs for production and quality employees to improve product excellence. Cross-Functional Collaboration: Coordinate work method updates with engineering and brief changes to the production team. Participate in all shop-wide continuous improvement activities and work with management to investigate other standards that enhance market competitiveness. Customer & Vendor Relations: Act as the technical liaison for customers by investigating feedback. Brief management on customer feedback and ensure timely notification of panel completions. Maintain procedures to mitigate risks of consumable shortages. Support the implementation and maintenance of the company's Quality Management System (QMS). Tool and Equipment Management: Abide by and enforce the implemented tool management program, monitoring equipment use and ensuring calibration requirements are met. Qualifications and Requirements: Candidates will only be considered if they clearly meet 100% of the following qualifications: Required Technical Experience: Advanced knowledge and hands-on experience with VFDs, PLCs, and other relevant electronic devices. Extensive experience with low-voltage electrical systems, specifically 480VAC. Proven ability to read, comprehend, and interpret complex electrical schematics and blueprints. Advanced knowledge of electrical theory and shop standards. Proficient/Advanced knowledge of Microsoft Excel for data analysis and reporting. Educational Background: Graduate of a technical school with emphasis in electrical work or Associate's Degree is required or equivalent experience. Professional Requirements: Solid work ethic with the ability to effectively and regularly communicate in English. Dependable, trustworthy, and possesses a positive and productive attitude. Ability to work a flexible schedule that includes extended hours. Must qualify for the UL - Manufacturing Technical Representative (MTR) role within 6 months with provided training. Willingness to submit to pre-employment, random, and for-cause drug testing. Physical Demands: Must be able to perform moderate physical activity, including lifting and/or moving up to 50 pounds, with exposure to loud noise and potential electrical hazards. Cognitive Skills: Ability to perform complex mathematical calculations, diagnose intricate electrical problems, and apply logical reasoning in troubleshooting scenarios. Other: All qualified applicants must satisfactorily pass the background screen and adhere to company policies. Other duties as assigned.

Posted 30+ days ago

N logo
Neurocrine Biosciences Inc.San Diego, CA
Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie) About the Role: Responsible for achieving operational goals for the Computerized System Validation (CSV/CSA) and Computer Software Assurance (CSA), impacting multiple systems. Manages the validation of new systems as well as changes to existing systems by working closely with IT and functional stakeholders to achieve a culture of continuous improvement along with ensuring CSV/CSA requirements are met. Leads GxP impacting projects to ensure that all applicable regulatory, quality, security, data privacy, and compliance requirements are met for any new or revised computerized systems to ensure that these systems are not only defendable during an inspection, but also confirm that the delivered systems/services are fit for purpose by meeting user requirements. _ Your Contributions (include, but are not limited to): Interface with internal and external partners to identify existing or potential computer system validation issues and collaboratively pursue solutions; evaluate proposed new computerized systems, data center hosting, networks, cloud and/or software to assess GxP impact and where GxP impact is identified provides guidance on the risk based validation approach for the system, working with key stakeholders to achieve business goals Leads assigned projects and/or supports in the development of validation deliverables including Validation Plans, Test Plans/Protocols/Scripts, Specifications and Design Documents, Compliance Assessments, Risk Assessments, Installation Qualification, System and User Acceptance Testing, Data Migration Plans, Traceability Matrices, Validation Reports, Supplier Assessments, etc Manage validation policies, procedures, and plans, recommend changes as needed Review incidents for GxP impact. Review proposed changes to validated computer systems/qualified IT infrastructure and identify the validation or qualification requirements necessary to maintain the validated/qualified state after execution of the change Provide compliance guidance to the IT function, business leaders, and stakeholders Maintain the controlled inventory of GxP computer systems, identify deficiencies in the validation status and prioritize remedial actions based on risk Establish and maintain standards and training materials for the specification, design, development, configuration, implementation, validation, use and maintenance of computerized systems which support the development, manufacture and distribution of pharmaceuticals in alignment with applicable worldwide regulations and standards Maintain up-to-date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer systems, and acts as an information resource for the team and wider business Provide QA and validation leadership for regulated computer systems and apply risk-based methodology to validation and qualification efforts in compliance with global regulatory requirements (21 CFR Part 11 and EU Annex 11 or equivalent international regulations) Design, implement, and govern overall readiness of CSV/CSA and Data Integrity programs to ensure programs are compliant and ready for regulatory inspections Provide Quality review and approval of Deviations, CAPAs, Change Controls and other quality events Participate and support the external audit program for vendors related to regulated computer systems Partner with key business stakeholders and senior management in the development of the computer system validation corporate strategy, provide subject matter expertise and lead the corporate wide CSV/CSA program through quality management and quality oversight activities intended to ensure overall global regulatory adherence Ownership of all CSV/CSA related policies and procedures, ensuring they meet organization needs and remain aligned to global regulatory guidance Other duties as assigned Requirements: BS/BA degree in computer science, scientific or related discipline and 6+ years of regulated industry experience in hosting/defending external audits and regulatory inspections OR Master's degree in computer science, scientific or related discipline and 4+ years of related experience Advanced understanding of 21CFR820, 21CFR11, Annex 11, GAMP 5, HIPAA, etc Ability to effectively convey compliance requirements to appropriate internal partners Ability to influence, negotiate, and constructively challenge to achieve productive solutions Maintains knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer systems Detailed technical understanding of computer system validation and infrastructure qualification, including the application of risk managed approaches A thorough understanding of drug development processes from discovery through development and post-marketing Advanced communication and presentation skills with an ability to adjust to both technical and non-technical audiences including business stakeholders and senior management Ability to manage competing demands in a fast-paced, dynamic environment where collaboration, communication, prioritization, and flexibility are key attributes for success Experience managing multiple projects, including partnerships with external partners, simultaneously from design through deployment Proactive quality support methodology that can translate complex regulatory principles into best practices for cross-functional teams Experience in developing an organizational "culture of quality" and risk-based validation activities Experience drafting, reviewing, implementing and ensuring compliance with validation procedures that drive efficiency and foster a creative approach to solving business needs Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products Experience in electronic software applications such as Electronic Document Management System (EDMS), Product Lifecycle Management (PLM), Quality Management Systems (eQMS), Complaint Management Systems, Enterprise Resource Planning systems (ERP), etc Experience in the utilization of risk analysis tools such as FMEA, FTA, etc Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines Works to improve tools and processes within functional area Developing reputation inside the company as it relates to area of expertise Ability to work as part of and lead multiple teams Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams. Excellent computer skills Excellent communications, problem-solving, analytical thinking skills Sees broader picture, impact on multiple departments/divisions Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency #LI-SA1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $117,300.00-$170,050.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Posted 3 weeks ago

P logo
Perrigo Company CorporateAllegan, MI
At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, ACO, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview The Lead QA Release Technician is responsible for reviewing batch records for accuracy and compliance with cGMP and applicable procedures to ensure that the product meets acceptable specifications. This includes auditing the batch record release process and leading continuous improvement initiatives across the Quality department. Scope of the Role Review batch records for compliance with cGMP and internal procedures. Audit documentation and batch release processes to ensure regulatory compliance. Coordinate training efforts across shifts, harmonize training initiatives, and serve as the point of contact for QA learning plans. Identify and implement lean projects for technician roles, including SME identification and cross-functional participation. Lead cross-shift projects, team-building activities, and process consistency efforts. Manage release office workload requirements. Serve as a Subject Matter Expert SME during internal and external audits as needed. Must have the ability to communicate clearly and execute on business needs with multiple departments such as planning and customer service. Other requirements as needed as directed by QA leadership. Experience Required High School Diploma or GED is required; Associate's or Bachelor's degree is preferred. Minimum of two (2) years of experience in an FDA-regulated industry. Six (6) years preferred for Lead-level responsibilities; fewer years may be considered with a degree. Excellent oral and written communication skills and strong interpersonal skills. Strong analytical skills, attention to detail, and ability to work independently and efficiently. Thorough understanding of cGMPs and ability to recognize variances. Preferred experience with: Manufacturing or packaging equipment and processes. Batch record review and documentation procedures. Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Find out more about Total Rewards at Perrigo. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo Nearest Major Market: Grand Rapids

Posted 1 day ago

Smithfield Foods, Inc. logo
Smithfield Foods, Inc.Kinston, NC
If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub. A great job-and a great future-awaits you at Smithfield Foods. We are an American food company with a leading position in packaged meats and fresh pork products. We're looking for motivated people who want to join our team and grow lasting and meaningful careers with us. Apply Now! THE VALUE YOU'LL BRING: The position summary states the general nature and purpose of the job. Overall accountabilities are defined in this section. As part of our Food Safety & Quality Assurance team, you will ensure our products meet the highest safety and quality standards. You will conduct sanitation checks, enforce HAACP and USDA regulations, and track products from start to finish, implementing corrective actions as needed. Overseeing FSQA programs in specific production areas, you will ensure compliance, train employees, and drive continuous improvement. With opportunities to step into FSQA Manager duties, you will play a vital role in delivering safe, high-quality products under brands like Smithfield, Eckrich, and Nathan's Famous. If you are passionate about food safety, quality and leadership, join us and make an impact! WHAT YOU'LL DO: The below statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned. Food Safety & Quality Assurance Leadership- You'll ensure that all Food Safety, Quality Assurance, SQF, and Regulatory programs are executed and documented accurately, maintaining compliance and product integrity. Your role will involve investigating and resolving product/process failures quickly, minimizing downtime, and ensuring safety and quality standards are consistently met. You will collaborate closely with plant management, production teams, and the USDA to drive continuous improvement in food safety, quality, and sanitation. Continuous Improvement & Compliance- You'll prevent failures by actively managing HACCP, SSOP, and product specifications. Leading efforts to improve product quality and processes in partnership with FSQA staff and Operations will be a key responsibility. Additionally, you will oversee and participate in plant committees and task forces, such as the Health and Safety Committee, to enhance safety and quality standards. Sanitation & SQF System Ownership- You will conduct operational and pre-operational sanitation inspections and micro sampling to ensure the effectiveness of sanitation practices. As the owner of the SQF system, you'll maintain and reassess the SQF Plan regularly, ensuring it remains compliant and up to date. You will also communicate key updates and ensure team-wide awareness for the effective implementation of the SQF system. Team Development- You'll manage the work assignments, training, and development of food safety and quality assurance staff, fostering a high-performance team that upholds the highest standards of food safety and quality. WHAT WE'RE SEEKING: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. Bachelor's degree from an accredited four-year college or university and 2+ years' relevant experience in food safety or quality assurance; or equivalent combination of education and experience. Experience acting as a lead by providing training, coaching or mentoring to less experienced staff or through managing a process or project. Familiarity with meat processing, USDA, HACCP, SSOP, and SQF Ability to uphold regulatory, company, and customer standards and address inquiries or complaints. OTHER SKILLS THAT MAKE YOU STAND OUT: HACCP and SQF certifications preferred. Ability to uphold regulatory, company, and customer standards and address inquiries or complaints. Proficiency in database, inventory, manufacturing software, QMS systems, SAP, and MS Office. Strong written and oral communication, with excellent decision-making and problem-solving abilities. Strong planning, multitasking, and project management skills. Must complete forms in English; ability to travel up to 20% and work extended hours or weekends as needed. Ability to work effectively in a fast-paced environment, fostering positive relationships and a team-oriented atmosphere. PHYSICAL DEMANDS & WORK ENVIRONMENT: The physical demands described here are representative of those an employee should possess to successfully perform the essential functions of this job. The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Office and plant setting. The plant environment will include wet or humid conditions (non-weather related), extreme cold and heat (non-weather related), working near moving mechanical parts, exposure to fumes or airborne particles, and chemicals. Occasionally lift and/or move up to 50 pounds Specific vision includes close vision, distance vision, and ability to adjust focus. Additionally ability to differentiate colors. Frequently required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. Noise level in the work environment is usually moderate but can be loud when in the production area. IndSPR-Ops Relocation Package Available No EEO Information Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law. If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.

Posted 30+ days ago

Gate Gourmet logo
Gate GourmetMiami, FL
We're looking for motivated, engaged people to help make everyone's journeys better. Position is responsible for food safety and quality engineering and control on processes supporting operation, system, policy and procedure auditing; leads quality improvement projects, drives defect prevention on flight attendant comments and detections. Acts as the primary business quality project manager for Corporate Quality Assurance requirements and regulations. Main Duties and Responsibilities: Supports all customer and regulatory audits within the responsible facilities Works side-by-side with Operation Managers to assure compliance to HACCP requirements are met Works as part of the corrective action team to address non-conformities related to product, process and service Executes monthly self-assessments on the elements of food safety Executes the required food safety related testing as defined in HACCP plan Plans for quality (capital, supplier quality, plant quality). Evaluates and reports on performance trends related to quality Manages Quality Engineering projects, including operative supportive functions Leads and monitors improvement projects as assigned Audits implementation of quality systems for effectiveness by verifying activities Responsible for maintaining and managing the corrective action system Monitors the accuracy and compliance of HACCP records as defined in the corporate procedures Reinforces quality awareness to the management and work staff Schedules and manages the daily activities and task of the sanitation porters (if defined as a responsibility) Manages continuous improvement projects in quality elements Plays a key role in implementing the business management system Implements the quality system detailed in the quality manual Champions quality improvement efforts and initiates problem solving efforts and assures implementation Drives prevention vs. detection of defects tracking key performance indicators and daily patrol of production areas Responsible to lead product defect investigations Responsible to lead investigations of alleged food poisoning, Hard-foreign and soft foreign objects Responsible to manage the compliance with USDA / APHIS regulations Responsible to manage food product suppliers of the unit including auditing of local suppliers Coordinates actions to prevent the occurrences of nonconformities to internal, Federal and State laws Maintains customer compliance resolution on defects including alleged food poisoning if needed Responsible for the identifying and maintaining of key performance metrics for the Quality organization Continuously improves plant procedures for monitoring and ensuring conformance to specifications for incoming raw materials as well as for finished products Acts as the primary liaison to Corporate QA Compliance Team Plays a key role in training and coaching of quality requirements to all levels in the business unit's organization Responsible for safety, quality and compliance to customer specification Ensures optimum business processes to support full customer and regulatory compliance in terms of quality and food safety Stays attuned to and prepares adaptation to changes in customer, company and regulatory changes in requirements At times liaises with customers and regulatory agencies Responsible for performance evaluation, coaching, counseling and preparing corrective action for employees and liaises appropriately with HR and other support functions Completes Hazard Analysis and Risk Based Preventative Controls (HARPC) Preventative Controls for Human Food training and certification course to be a PCQI "Preventive Controls Qualified Individual" according to company policy. Completes all other company required training including but not limited to ServSafe Sanitation Manager Certification.QualificationsEducation: Bachelor's degree in food science, quality, technical or business related field from an accredited 4-year college or university requiredWork Experience: Minimum of 5 years quality assurance experience in a manufacturing environment, with preference in food manufacturingJob Skills: Advanced technical knowledge in catering processes and design functions, manufacturing methods, inspection, statistical methods and quality auditing Knowledge of lean standard tools, TQM methodology Basic lean, six sigma knowledge, and continuous improvement understanding a plus Detail oriented Project management experience Strong organizational skills, able to prioritize responsibilities and multi-taskTechnical Skills: (Certification, Licenses and Registration) ServeSafe certification preferred HACCP certified Language / Communication Skills: Strong interpersonal skills, interact well with multiple departments as required Able to work with little supervision Excellent reading, writing, and oral communication skills Change Agent Multi-lingual a plusJob DimensionsGeographic Responsibility: USType of Employment: Full timeTravel %: 20%Exemption Classification: ExemptInternal Relationships:External Relationships:Work Environment / Requirements of the Job: Regularly stands, bends, lifts and moves intermittently during shifts. Must be to lift, pull, push, and move products, equipment, and supplies daily. There may be physical discomfort due to temperature in production area, coolers, and freezersBudget / Revenue Responsibility:Organization StructureDirect Line Manager (Title): General ManagerDotted Line Manager (Title, if applicable): Sr. Compliance ManagerNumber of Direct Reports:Number of Dotted Line Reports:Estimated Total Size of Team:gategroup Competencies Required to be Successful in the Job: Thinking- Information Search and analysis & problem resolution skills Engaging- Understanding others, Team Leadership and Developing People Inspiring- Influencing and building relationships, Motivating and Inspiring, Communicating effectively Achieving- Delivering business results under pressure, Championing Performance Improvement and Customer FocusDemonstrated Values to be Successful in the Position Employees at gategroup are expected to live our Values of Excellence, Integrity, Passion and Accountability. To demonstrate these Values, we expect to observe the following from everyone: We treat each other with respect and we act with integrity We communicate and keep each other informed We put our heads together to problem solve and deliver excellence as a team We have passion for our work and we pay attention to the little details We foster an environment of accountability, take responsibility for our actions and learn from our mistakes We do what we say we will do, when we say we are going to do it We care about our coworkers, always taking an opportunity to make someone's day betterThe above statements are intended to describe the general nature and level of work being performed by the individual(s) assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required. Management reserves the right to modify, add, or remove duties and to assign other duties as necessary. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. Candidates will be required to go through Pre-employment drug screen, criminal background check, and/or airport fingerprinting. gategroup is an equal opportunity employer committed to workforce diversity. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status or other category under applicable law. For further information regarding Equal Employment Opportunity, copy and paste the following URL into your web browser: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf We anticipate that this job will close on: 09/29/2025 For California Residents, please click here to view our California privacy notice. If you want to be part of a team that helps make travel and culinary memories, join us!

Posted 1 week ago

Dreyer's Grand Ice Cream logo

Supr Facility QA

Dreyer's Grand Ice CreamLaurel, MD

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Job Description

Are you looking to catapult your career by driving high-impact transformation with household brands? Do you crave an entrepreneurial, fast paced and engaging growth assignment working with incredible people from across the globe?

At Dreyer's Grand Ice Cream, we are excited to start a new chapter of accelerated growth as part of Froneri - a global pure-play ice cream leader. Come help us transform DGIC into the #1 ice cream brand! With nearly 100 years of winning experience in the U.S, a robust portfolio of powerhouse brands that consumers know and love such as Häagen-Dazs, Drumstick, Dreyer's & Edy's, and the backing and coaching of European-based ice cream experts, we know we have the winning recipe.

Headquartered in Walnut Creek, the Bay Area's hub for up-and-coming food trends, our teams across our offices and factories are raising the bar on all things ice cream. We are investing in significant capital expansions to grow our Operations and Supply chain and are transforming how we work at every level to become agile, accelerate growth and elevate our quality. With a renewed focus on frozen treats, our tight-knit team of ambitious innovators are fully immersed in the business and encouraged to flex and make decisions quickly. We are committed to pursuing every great idea and delivering the best ice cream experience for our consumers, when and where they want it.

Unleash your potential at Dreyer's Grand Ice Cream and discover what a sweet career we have in store for you!

Developing high quality standards and ownership across value chain

Job Description:

The Quality Supervisor ensures compliance with food safety regulations, monitors production processes, and implements quality control measures to maintain the highest standards in ice cream production. They work closely with production, R&D, and regulatory teams to ensure consistency and excellence in the final product.

  • Lead by example to carry out all duties and specific responsibilities operational Quality and Food Safety Policies and Procedures.
  • Promote the culture change towards behavioral quality improvements
  • Provide expertise to operations for promoting and executing quality to provide customers with exceptional ice cream experience
  • Direct and supervise the quality specialists and quality techs to ensure daily activities promote production of quality ice cream products on the lines
  • Partner with operations management on key quality checks to be completed by line operators.  Checks need to be evaluated periodically to ensure they are in line with hold and complaint data.
  • Manage quality hold program and partner with operations to complete lesson learnt (root cause) and implement corrective action identified. Provide trend data to demonstrate effectiveness of corrective action implementation.
  • Provide leadership on customer complaint reduction by partnering with operations on strategies to reduce complaints by using complaint trend data to prioritize actions.
  • Oversee and provide leadership on the net content to establish facility specific rules to ensure compliance to both volume and weight targets
  • Provide support to TAG on new product launches or formulation when requested.
  • Identify, communicate to plant operations and apply "Best Practices" within the facility or from the broader network.
  • Drive improvements and monitor Quality Metrics/KPI's at the facility
  • Challenge all departments on quality and food safety related
  • Provide support to GMP and HACCP, FSMA FSP compliance through out the facility, by coaching operators when on the floor and promoting minimal water use during production.
  • Ensure compliance to internal and external audits i.e. FSSC 22000/Market audits
  • Provide support to local, State and Federal agencies when requested by local quality management
  • Drive Monthly reviews of KPI's and contribute towards meeting the yearly business goals for the facility.
  • Monitor and assess performance of the quality systems, report their effectiveness to management and implement actions for improvement
  • Represent The Froneri Way of working through the behaviors and characteristics in our Operating Model and Core Values

Measurable Outcomes

CPMU reduction

  • Respect of GMP and distribution of the "lesson learnt "
  • Reduction of pallets on holds
  • Reduction of food safety incidents
  • Being on the shop floor making ice-cream
  • Drive improvements from benchmarking improvements

Levels of responsibility

  • Deploy QA standards
  • Achieve QA targets defined at market level (CPMU, RFT, CRQS…)
  • Hold program
  • Net Content execution

Qualifications & Requirements:

  • Bachelor's degree in Food Science, Microbiology, or a related field.
  • 2+ years of experience in quality assurance, preferably in the dairy or frozen food industry.
  • Knowledge of HACCP, GMP, and food safety regulations.
  • Strong attention to detail and problem-solving skills.
  • Ability to lead a team and work collaboratively across departments.
  • Proficiency in quality control software and reporting tools.

BEHAVIORS AND CORE VALUES: Must consistently showcase the desired behaviors that represent our Core Values.

We Take Ownership

  • Stay committed to responsibilities from start to finish
  • Make sound decisions and get into the right level of detail
  • Apply resources to initiatives that add growth, improve efficiencies, or reduce waste

We Do What Is Right

  • Choose transparency over convenience, even if it means difficult conversations
  • Set clear roles and responsibilities, enabling everyone to exercise appropriate initiative and judgment
  • Speak up when you see something that does not align to our values and policies

We Seek to Improve

  • Strive to continuously improve and innovate to exceed expectations
  • Value feedback from others and encourage open dialogue to understand how we can improve
  • Learn from both successes and failures

We Are Better Together

  • Ensure decisions are based on what's best for the whole business
  • Practice inclusion by seeking diverse perspectives
  • Treat everyone with fairness and respect

Work Environment

In this position, the employee will regularly work with and around others; in a wet and/or humid environment; in areas of high noise level; and around mechanical, electrical, and pressurized equipment. The work is fast paced.

  • Cold Temperatures: Parts of the facility, such as storage and production areas, may be kept at low temperatures.
  • Requires use of cold-protective PPE.
  • May involve standing, lifting, and walking in refrigerated zones for extended periods.
  • Fast-Paced: Workers often operate under strict timelines to meet production quotas.
  • High-speed manufacturing floor with frequent movement, line assignment changes, and tight production timelines.
  • Standing for Long Hours: Many roles require prolonged standing and repetitive tasks.
  • Repetitive hand and arm movements required.
  • Must be able to stand for hours with frequent bending, reaching, and lifting.
  • Food Safety Regulations: Employees must follow hygiene and safety guidelines, including wearing protective gear (gloves, hairnets, etc.).
  • Team-Oriented: Workers collaborate to ensure smooth production and packaging.

The position involves frequent exposure to nuts and other potential allergens.

The pay scale for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. At Dreyer's Grand Ice Cream, it is not typical for an individual to be hired at or near the top of the range for their role, and compensation decisions are dependent on the facts and circumstances of each case. The pay range for prospective employees in this role is between $75,000.00 and $90,000.00 per year, with opportunities for overtime, shift differential, cold premium pay and annual bonuses (variable depending on company performance).

We offer a comprehensive group benefits package including medical, dental, vision, life, paid time off, paid holidays, paid parental leave, 401K plan with employer match and annual contribution available.

Dreyer's Grand Ice Cream Inc. provides equal employment opportunities for all applicants, regardless of race, religion, gender, national origin, age, disability, marital status, veteran status, or any other protected characteristic.

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