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Lonza, Inc. logo
Lonza, Inc.Bend, OR
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. Lonza Pharma & Biotech is looking for a Manager, Compliance & Validation to join the Quality Assurance team in Bend, OR. This role provides an outstanding opportunity to lead an exceptional QA team in a company that values innovation and collaboration. Join us and help drive the future of life sciences forward! Key Responsibilities: Provide assistance in internal audits, audits from external parties, and regulatory inspections of designated Quality Management Systems as the QA subject matter expert. Maintain current knowledge of applicable regulations, mentorship, and standards, and train personnel on cGMPs and applicable regulations. Participate in compliance evaluation of regulated activities within pharmaceutical development and cGMP manufacturing. Report to management any departures from regulations and cGMP noted during the assessment of manufacturing operations, internal audits, supplier audits, external audits, and regulatory inspections. Help in identifying necessary CAPA and validate the successful execution and efficacy of assigned measures. Develop efficient workflows and processes, and appropriate metrics to track compliance, efficiency, and efficiency. Manage and supervise designated aspects of the Quality Assurance and Management System. Ensure procedures, systems, and processes are effective and meet regulatory requirements and business needs. Supervise QA staff at various levels responsible for lifecycle management of quality system documents. Review and approve regulatory documents. Perform other duties as assigned. Key Requirements: Bachelor's Degree or equivalent experience required. Significant experience in the pharmaceutical/biotech industry. Compliance and Regulatory experience required. Prior Management experience required. GMP (Good Manufacturing Practices) experience preferred. Strong leadership, writing, and communication/presentation skills are required. Must be independent, self-motivated, organized, able to multi-task, and skilled in communication, facilitation, and collaboration. Individual must be a great teammate prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. 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 30+ days ago

Arthrex, Inc. logo
Arthrex, Inc.Ave Maria, FL
Requisition ID: 63270 Title: Sr. Engineer QA - Manufacturing Division: Arthrex Manufacturing Inc (US02) Location: Ave Maria, FL Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer Sr- QA for our manufacturing site in Ave Maria, FL. The Sr Engineer- QA is responsible for various Quality Assurance functions for the manufacturing development of medical devices. The ideal candidate with have a Bachelor's degree in Engineering and 5+ years experience with continuous improvement manufacturing processes in a highly regulated industry. This position requires leadership skills, the willingness and ability to mentor Quality Assurance team members. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better. Essential Duties and Responsibilities: Participates in the development of medical devices and components from design initiation through design transfer and by representing Quality Assurance for manufacturability in all design and development project teams. Participates in all manufacturing activities to assure compliance of design specifications. Leads development of quality plans of new product introductions based on designspecificatons, PFMEA, and control plans. Works with design team and assist/provide feedback on design specifications and improvements. Evaluates and develops effective and efficient methods of testing and inspection of products. Utilizes problem solving tools and techniques and apply risk based approach to problem solving. Determines necessity of testing and initiates testing by preparing test and inspection plans, and identifying and obtaining required test fixtures and test/inspection instrumentation. Initiates new projects and acts as the project leader for key initiatives, identifies best practices. Provides technical support on manufacturing technical issues. Performs quality trending and leads/supports process improvement initiatives. Approves manufacturing product and process changes and assures the change management is controlled, adequate, and documented. Ensures information and documentation is consistently accurate. Responsible for MRB activities for assigned products, timely resolution of nonconformities, issuing and/or monitoring corrective actions associated with nonconformance and deviations. Provides input and direction to other members of the quality assurance department to assist them in their assignments and provide them with learning experience. Supports manufacturing suppliers with assistance in on-site resolution of quality and process related issues andcorrective and preventive actions. May supervise other engineers, technicians, and support personnel. Education and Experience: Bachelor's degree in Engineering required 5 years experience in a Quality Control or Quality Assurance position required, preferably in a medical device company. Knowledge and Skill Requirements/Specialized Courses and/or Training: Working knowledge of risk assessments, design control requirements, PFMEAs, control plans, quality plans, testing and inspection equipment and techniques. Manufacturing process knowledge. Technical knowledge in development methodologies, design, project implementation, including, but not limited to GD&T, DOE, verification, and validation. SPC (Staticstical Process Control) knowledge. Strong communication skills and ability to communicate effectively with technical and non-technical staff. Project management skills preferred. Recognized process improvement (i.e.: Lean, Six Sigma) and problem solving (i.e.: RCA, DMAIC, 5 Whys) training preferred. Machine, Tools, and/or Equipment Skills: Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), QAD or similar inventory software. Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Mathematical Skills: Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. Language and Communication Skills: Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management.Ability to write and record data and information as required by procedures. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Vision Requirements: Visual acuity necessary to do the job safely and effectively. Specific vision abilities required by this job include close vision. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Arthrex Benefits Medical, Dental and Vision Insurance Company-Provided Life Insurance Voluntary Life Insurance Flexible Spending Account (FSA) Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) Matching 401(k) Retirement Plan Annual Bonus Wellness Incentive Program Free Onsite Medical Clinics Free Onsite Lunch Tuition Reimbursement Program Trip of a Lifetime Paid Parental Leave Paid Time Off Volunteer PTO Employee Assistance Provider (EAP) All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law. Making People Better at Arthrex Lorem ipsum dolor sit amet consectetur. Cras fringilla elementum odio velit. Job Details Date: Nov 7, 2025 Requisition ID: 63270 Salary Range: Job title: Sr. Engineer QA - Manufacturing Arthrex Location: Ave Maria, FL, US, 34142 Nearest Major Market: Naples Job Segment: Quality Assurance, Medical Device, Testing, Manufacturing Engineer, Lean Six Sigma, Technology, Healthcare, Engineering, Management

Posted 30+ days ago

L logo
Legend Biotech CorpRaritan, NJ

$81,273 - $106,669 / year

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 QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role Overview The QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and complaint product supply. Key Responsibilities Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs. Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues. Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints. Review and approve manufacturing procedures. Support regulatory inspections and audits by ensuring inspection readiness within facility. Perform internal housekeeping audits. Perform analysis on quality indicating data and identifying trends. Provide oversight for trending of quality compliance metrics. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning. Requirements A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required. A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices. Great attention to detail and ability to follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a must. Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. Must exhibit strong leadership skills and effectively develop others. Ability to collaborate well with stakeholders, customers and peers. Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Must be able to discern the criticality of issues and to communicate to management regarding complex issues. Ability to manage conflict and issues that arise with internal or external customers. #Li-BG1 #Li-Onsite The anticipated base pay range is $81,273-$106,669 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

NASDAQ Omx Group, Inc. logo
NASDAQ Omx Group, Inc.Philadelphia, PA
We are looking for QA Test Analyst candidate in our Market Systems Options - Quality Assurance department in Philadelphia location. You will provide automated, and manual functional testing of our most highly visibility products. You will help design test plans for new projects and ensure that testing procedures are consistently followed. You will use tools to report issues and consistently track status. You will bring an ample degree of knowledge to your position, which will help you in implementing a testing methodology maximized to the needs of the group. This role involves reviewing system requirements, debugging software, reporting issues, and collaborating with development, project management, and implementation teams. You may also contribute to the development of internal testing tools and specialize in Quality Assurance, Quality Control, or Process Improvement. You are an excellent communicator. Automated and manual functional testing of new products/product features as well as automated regression testing of existing functionality. Automated and manual QA testing of Amazon Web Services cloud setup, configuration, and execution. Writing, reviewing, and updating product test plans, test cases, automated test scripts, and scenarios. All tiers of testing - manual, automated, front-end, and back-end. Execution of test plans, automated test scripts and test cases to ensure that software meets or exceeds specified standards, development specifications, and/or client requirements. Build and maintain test tools and test applications to perform automated functional and regression testing. Work closely with development, product development, and operations departments to ensure quality and timely services are delivered to clients. Adaptability and Learning Mindset: Demonstrating a willingness to learn new technologies, tools, and methodologies is crucial. Adaptability to changing project requirements and the ability to work in a dynamic environment is highly desirable. Programming Skills: Proficiency/Good Understanding in at least one programming language is crucial. Python/Java. Knowledge of scripting languages like Bash or PowerShell will be valuable. AI knowledge will be a great plus System and Network Knowledge: Understanding of operating systems (e.g., Windows, Linux, Mac ), databases (e.g., SQL), and computer networks is important. should be familiar with concepts such as client-server architecture, network protocols, and basic system administration tasks. Bug Tracking and Management Tools: Familiar with bug tracking and test case management tools, such as JIRA is beneficial. Being able to effectively log, track, and communicate issues is essential for efficient collaboration with development teams. Review system requirements and business processes. Maintain testing tools to be used by the broader team. Leverage AI-assisted tools (e.g., GitHub Copilot, GenAI test generators) to speed up test case creation and script development. Education Required: Bachelor's degree or higher in computer science, Information Systems or related discipline, or equivalent work experience. Experience Required: At least 1 year preferably 2 year. Strong attention to detail and a creative thinker. Self-motivated (self-starter) and intellectually curious. Experience with LINUX command-line environments Experience with automation frameworks and tools Knowledge on Database (SQL) and Programming knowledge will be a huge plus Knowledge of AI will be valuable Leverage AI-assisted tools (e.g., GitHub Copilot, GenAI test generators) to speed up test case creation and script development. Applicants must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future; Nasdaq will not sponsor applicants for U.S. work visa status for this opportunity (no sponsorship is available for H-1B, L-1, TN, O-1, E-3, H-1B1, F-1, J-1, OPT, CPT or any other employment-based visa) This position can be located in Philadelphia, and offers the opportunity for a hybrid work environment (at least 3 days a week in office, subject to change), providing flexibility and accessibility for qualified candidates. Come as You Are Nasdaq is an equal opportunity employer. We positively encourage applications from suitably qualified and eligible candidates regardless of age, color, disability, national origin, ancestry, race, religion, gender, sexual orientation, gender identity and/or expression, veteran status, genetic information, or any other status protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. What We Offer We're proud to offer a competitive rewards package that is meaningful, recognizes the unique needs of our employees and their families and incentivizes employees for their contribution to Nasdaq's overall success. In addition to base salary, Nasdaq offers significant other compensation (annual bonus/commissions and equity), benefits, and opportunity for growth. Exact compensation may vary based on several job-related factors that are unique to each candidate, including but not limited to: skill set, experience, education/training, business needs and market demands. Nasdaq's programs and rewards are intended to allow our employees to: Secure Wealth: 401(k) program with 6% employer match, Employee Stock Purchase Program with 15% discount, Student loan repayment program up to $10k, Company paid life and disability plans, Generous paid time off Prioritize Health: Comprehensive medical, dental and vision coverage, Health spending account with employer contribution, Paid flex days to support mental wellbeing, Gym membership discounts Care for Family: Hybrid home/office schedule (for most positions), Paid parental leave, Fertility benefits, Paid bereavement leave Connect with Community: Company gift matching program, Employee resource groups, Paid volunteer days Grow Career: Education Assistance Program, Robust job skills training and Professional development opportunities For more information, visit Nasdaq Benefits & Rewards Career page.

Posted 30+ days ago

L logo
Leslie's Pool Supplies (DBA)Sauget, IL

$28 - $30 / hour

DIVE IN TO A NEW CAREER WITH A LESLIE'S COMPANY: In September 2022, Stellar Manufacturing was acquired by Leslie's as an affiliate. Stellar Manufacturing is a contract manufacturer of solid particle products and specializes in chemical processing services such as specialty tableting, compaction granulation, and granular filling. We support the manufacturing of a variety of consumer and industrial products including water treatment chemicals, janitorial and sanitation products, agrochemicals, raw materials, and more. With over 30 years of providing best-in-class products and solutions to our customers, there is nothing that we value more than the development and growth of our team. Both Leslie's and Stellar strive to create a positive and fun atmosphere where our Team Members feel valued and are enthusiastic about the contributions they make to the success of Stellar. Summary: The QA Specialist - Positive Release is primarily responsible for ensuring that all manufactured products have been verified against their quality acceptance criteria and are authorized for shipment according to the organization's quality management system which meets the requirements of ISO 9001:2015 standard. Responsibilities: Core duties and responsibilities include the following. Other duties may be assigned. Review and approve production batch records with the requirements of current GMPs. Review and approve inbound and outbound shipping paperwork Review and approve quality data which supports the generation of product COAs. Review and approve incoming raw material COAs. Follow good documentation practices when creating, reviewing, revising, obsoleting, and archiving controlled documents per the QMS. Support change management processes, deviations, and CAPAs as required. Monthly reporting to management on all outstanding NCAPs. Partake in internal and external auditing processes to provide supporting documentation as required. Support site risk management and continuous improvement efforts according to the site QMS. Data entry and review in Excel Performs other duties and special projects as assigned. Qualifications: Bachelor's Degree or equivalent work experience Technical Writer (1 year preferred) Ability to read, write and speak English to properly communicate information related to job functions, test methods, procedures, training requirements and specifications, etc. Must be well-organized with a high attention to detail skillset. Must have great oral and written communication skills as this position works closely with site management. Self-directed and motivated Must be able to work in environments that have minimum supervision as well as cross-functional teams Proficient with Microsoft Word, Excel, and Office. PHYSICAL DEMANDS: Employee must be able to sit, stand, type for extended periods of time. Employee may be exposed to various chemicals. Pay $28 - $30/Hour #FieldHiring

Posted 30+ days ago

AYR Wellness logo
AYR WellnessGainesville, FL
Company Description Ayr Wellness is a leading U.S. multi-state cannabis operator with more than 90 licensed retail locations across Florida, Massachusetts, Pennsylvania, Ohio, New Jersey, Nevada, and soon, Virginia. We cultivate, manufacture, and sell a broad portfolio of high-quality cannabis products, proudly serving both medical patients and adult-use consumers across our markets. At Ayr, our strength lies in our people. We're re-imagining how we work across every part of our business, and we're looking for builders and doers to roll up their sleeves and help shape what's next. The cannabis industry is fast-moving, complex, and full of opportunity. Together, we're not only shaping a company, but also building the future of cannabis. At Ayr you'll have the opportunity to make a lasting impact while growing your career alongside a company positioning itself for long-term success. For more information, please visit www.ayrwellness.com. Job Summary The QA Technician will perform quality assurance/utilization review duties, assist with product testing, and conduct routine inspections to provide data for use in the correction of potential problems and to meet requirements of regulatory agencies. Duties and Responsibilities Ensure all cannabis and cannabis containing products produced at the facility are processed and tested in accordance with regulatory agencies Assist QA team with sample preparation Create and review transportation manifests/sample submission forms for test samples. Ensure proper tracking of lab samples using appropriate systems Communicate to QA Lead or QA Manager when quality issues occur. Review and document all test results. Assist in monthly GMP/Sanitation/Security inspections and follow up on corrective actions Assist in investigating consumer complaints by determining root cause, implementing corrective actions and preventive measures, responding to complaints in the required timeframe, and analysing complaint trends. Maintain records for GMP training, including QPs, SOPs etc. Ensure all employees are trained on the procedures for their departments Follow all Good Manufacturing Practices as outlined in the QA Manual Qualifications Must meet the age requirement as outlined by state cannabis agencies Able to pass all background checks/fingerprinting as required by state cannabis agencies Able to provide valid badging/credentials as required by state cannabis agencies Education High school diploma/GED required Experience 1-3 years working in the cannabis industry, a laboratory, or in quality assurance preferred. Competencies (Knowledge, Skills, and Attitude) Customer Obsessed: Dedicated to creating a remarkable experience for both internal and external customers; builds rapport and maintains meaningful and effective relationships creating trustful, authentic connections; viewed as a good listener and is easy to approach and talk to and is often in the know early in any given situation. Priority Setting- Invests their time and others on what's important to deliver business results; quickly and effectively collaborates bringing together the collective intelligence of critical team members and prioritizes what needs to be done to reach the goal; quickly senses opportunities and obstacles in accomplishing a goal; eliminates roadblocks and creates focus that drives success and results. Results Oriented- Empowered with the knowledge of their potential this person learns quickly when facing new problems; a relentless and versatile learner, open to change, analyzes successes and failures for continuous improvement, experiments and will try anything to find solutions that support an ecosystem of knowledge; enjoys challenge of unfamiliar tasks, quickly grasps the essence and underlying structure of anything. Functional/Technical Skill- Possesses functional and technical knowledge and skills to perform at a high level of accomplishment; understands how their job function supports being a force for good Direct reports No direct reports Working conditions This person may be exposed to dust, kief, cleaning chemicals, and fumes. Although systems are in place to remove these byproducts, there is still exposure to some degree. This person will be travelling between dispensaries and manufacturing facilities within AYR Wellness. Physical requirements Must be able to stand for extended periods of time, and safely lift up to 25lbs Must be able to wear required Personal Protective Equipment (PPE) for extended periods of time (i.e. gloves, lab coat, hair net) Appropriate grooming for work environment (no jewelry, hair must be tied back, no hair outside of PPE) Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. AYR Wellness is an equal opportunity employer. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We do not discriminate on the basis of race, color, religion, creed, national origin, ancestry, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, genetic information, marital status, military or veteran status, or any other protected status in accordance with applicable federal, state, and local laws.

Posted 30+ days ago

Helix Electric logo
Helix ElectricSandy, UT
The electrical Quality Control Manager is responsible for working closely with the Project Manager and Superintendent to support the department with QAQC and final commissioning implementation and execution. DETAILED JOB DESCRIPTION: Helix Electric was founded in 1985 and is now one of the nation's largest and most successful electrical contracting companies. Our commitment to empowering people and powering projects is realized by our exceptional team of dedicated and highly skilled experts working together and never settling for good enough. We are proud of the team-oriented and employee-empowered business approach that defines our unique character. DESCRIPTION OF DUTIES & SCOPE: Work closely with project management team to coordinate all required testing and inspection reports as required by the project requirements. Work closely with project engineering team to help facilitate submissions of testing and inspection reports as required. Development and execution of project required QC Plan Assist with the coordination efforts related to formal notifications as required. Lead all vital QC documentation - Reports, Test Data, Logs, QC Daily Reports etc. Cross-reference and back-check all required testing standards for compliance. Work closely and coordinate with 3rd party testing firms as needed. Regular site walks on the project site to support and verify QC activities. Work with the Superintendents and Field personnel to promote adherence to QC standards when needed. Ensure quality control procedures and safety guidelines are adhered to. Work proactively and productively with the project team to assess and correct any potential deficiency items. Work collectively with the commissioning team. Provide top service to our clients with consistent and concise communication. QUALIFICATIONS: Minimum of 5 years in the electrical construction field Minimum of 2 years of management experience in construction environment performing QA/QC auditing Experience with electrical equipment and conductors to ensure safe testing, QC, and commissioning. Experience with safe start-up of electrical systems Experience with de-energizing, Lockout tag of electrical systems Working knowledge of NFPA 70 (NEC) and 70E (Electrical Safety in the Workplace) Excellent knowledge of data acquisition systems (monitoring, communications, networking) Up to date and current computer knowledge, including Excel, MS Office, email, internet, DAS software, interface systems, Bluebeam. Strong communication and interpersonal skills, teamwork attitude Clean DMV, drug test results, and background check

Posted 30+ days ago

Eli Lilly and Company logo
Eli Lilly and CompanyIndianapolis, IN

$118,500 - $173,800 / year

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. 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 unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 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. #WeAreLilly Responsibilities: The Associate Director- Quality Assurance (QA) is responsible for managing the activities of QA personnel supporting the oversight of Insulin or Peptide Purification Active Pharmaceutical Ingredient (API) manufactured within Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing site. The Associate Director- QA is primarily responsible for the productivity and development of the QA employees, the quality of the product/results, oversight of manufacturing and support operations and overall customer service. It is expected that the Associate Director will oversee the department's performance, resolution of quality issues, and regulatory compliance. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives. Inspection Readiness focus through developing and maintaining processes that support inspections and audits; prepare individuals to interact with inspectors and auditors. Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency inspections. Conduct performance management and development of QA staff; Partner within QA and across functional disciplines to influence and implement the site continuous improvements, site business plan objectives, and GMP Quality Plan objectives Provide coaching/feedback to and develop QA employees. Utilize Human Resources tools to ensure that the right individuals are in the right job (e.g., Performance Management, Merit Delivery, Talent Assessment, Succession Planning and Staffing). Participate in organizational planning. Provide input into the business plan and ensure conformance to department budget for area of responsibility. Exhibit cross-functional influence. Maintain and improve quality systems. Review and approve deviations, procedures, protocols, and change controls with focus for improving the overall manufacturing and/or business processes Participate in self assessments and regulatory agency inspections. Ensure internal and external quality and supply commitments are met. Provide quality management oversight for API manufacturing, laboratories and warehouses. Investigate complaints. Manage the creation, revision and maintenance of cGMP documents (e.g., job aids, procedures, forms, job descriptions). Provide oversight and review of changes to the Global Quality Standards and ensure local implementation of changes. Network with other sites regarding new or current quality systems. Basic Qualifications: Bachelor's Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field. 5+ years of experience in pharmaceutical manufacturing environment in any of the following associated disciplines: TSMS, Production, Quality Assurance, Quality Control, Engineering, Project Management, Development, Procurement. Additional Skills/Preferences: Experience in Manufacturing, QC, QA, Technical Services, Engineering or Regulatory Affairs. Excellent interpersonal skills and networking skills. Ability to organize and prioritize multiple tasks. Demonstrated strong problem solving and analytical thinking skills with strong attention to detail. Demonstrated understanding of computer applications. Demonstrated strong written and verbal communications skills. Ability to influence and lead diverse groups; communicate and influence effectively across functional groups and stakeholders Understanding of statistical tools and analysis. Previous experience supervising/leading people. Influences complex regulatory, business, or technical issues within the site and function Builds relationships with internal and external customers and partners Demonstrated Project Management skills and ability to coordinate complex projects Strategic thinking and ability to balance short term needs with long term business evolution Enthusiasm for changes, team spirit and flexibility Additional Information: Minimal travel ( Some off-shift work (night/weekend) may be required to support 24/7 operations Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE. Must carry a work mobile to support 24 hour/day operations. This role is onsite with the ability to work from home four days per month. 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 $118,500 - $173,800 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 30+ days 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, 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 Please note this is a 2nd shift position. Additional hours may be required and is dependent on the needs of the organization and/or department. Scope of the Role The QA Technician responds to quality events, completes related documentation, and determines immediate physical containment and remediation. They assist in identifying, assessing, and containing defects, and conducts ASP's and manages the rework process including providing rework instructions. The QA Tech also reviews documentation as necessary and performs auditing of Perrigo manufacturing and packaging process to ensure that processes are in compliance with applicable cGMP requirements. Experience Required High school diploma or GED is required, with preference given to those with advanced education (2-year or 4-year degree, or progress toward a degree). A minimum of 2 years experience working in an FDA regulated industry is preferred; at least 6 months of experience is required. Must possess an understanding of and ability to apply cGMPs. Must have a working knowledge of SOPs and be able to provide clear direction and interpretation. Strong analytical skills are required. Excellent oral and written communication skills are essential, as are strong interpersonal skills. The ability to work independently against multiple deadlines is required. Must be able to understand equipment operation and manufacturing/packaging processes. 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 3 days ago

Niagara Bottling logo
Niagara BottlingDallas, TX
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 Technician Lead Responsible for executing corporate and plant specific Food Safety, Quality and Laboratory requirements. The QA Technician Lead reports to QA Supervisor. In the absence of the Quality Assurance Technician Lead, the QA Supervisor or designate will assume the job duties. Essential Functions Ensure all parameters of food safety and quality are being adhered to and maintained throughout the facility. Assist with batching chemicals/ingredients for production. Calibrate lab and line equipment for accurate results. Collect in-process and finished product samples. Conduct standardized qualitative and quantitative testing to ensure it meets specifications. Perform aseptic testing for microbial contamination. Follow protocols for documenting testing results. Recognize deficiencies and initiate proper follow-up. Identify and isolate product that does not meet standards. Aid in troubleshooting deficiencies and non-conformances. Review food safety and quality records. Actively participate in plant teams (HACCP, Safety, etc.) Conduct other duties as assigned by management. 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: 4 Years- Experience in Field or similar manufacturing environment 4 Years- Experience in Position 4 Years- Experience managing people/projects experience may include a combination of work experience and education Must read, write and communicate in English. Must be able to work 12-hour shift (days or nights) on a rotating schedule Must follow GMP Policy - wear company issued shirt, hat, safety glasses, earplugs and hairnet in production areas. Able to lift up to 50 lbs. Able to work under pressure in a very fast paced environment Preferred Qualifications: 6 Years- Experience in Field or similar manufacturing environment 6 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 Makes safety the number one priority Keeps alert for safety issues and escalates immediately Effectively prioritizes tasks based on department goals Shows respect to others and confronts interpersonal issues directly Prioritizes resolution of customer issues effectively Responds promptly and honors commitments to internal and external customers InnovACT Makes recommendations to continuously improve policies, methods, procedures, and/or products Demonstrates adaptability by reacting appropriately to unexpected changes in situations or circumstances Increases performance through greater efficiency Find a Way Seeks to develop technical knowledge through learning from other experts Understands interdepartmental impact of individual decisions and actions Seeks solutions rather than placing blame Empowered to be Great Consistently looks for ways to improve one's self through growth and development opportunities Communicates clearly and promptly up, down, and across Communicates effectively to manage expectations Education Minimum Required: High School Diploma Preferred: Associate's Degree Certification/License: Required: HACCP, PCQI Preferred: Better Process Control Certification Foreign Language Required: Full Professional Proficiency 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 DALLAS

Posted 30+ days ago

Agtonomy logo
AgtonomySouth San Francisco, CA

$145,000 - $180,000 / year

About Us Agtonomy brings intelligent automation to agriculture, turf, and other demanding industries through Physical AI and software services. By partnering with trusted equipment manufacturers, we deliver factory-fit technology that transforms industrial machines into smart, efficient solutions built for safety and performance. Our team combines expertise in technology, product development, and industry knowledge to address critical challenges like labor shortages, sustainability, and productivity. We're looking for people who want to work in a collaborative, fast-moving environment where their ideas can make a real impact. About the Role Agtonomy's QA team is seeking a hands-on System and Software QA Manager to make an immediate impact leading the test and deployment of new features, system updates, and software releases. This role will be in the driver's seat building a high quality, repeatable test approach which unlock agricultural autonomy at global scale. What You'll Do Lead and grow a high-performing QA team, providing clear direction, coaching, and career development for engineers across multiple domains. Own test strategy for both software and integrated system validation, including unit, integration, HIL, simulation, and on-system testing. Model a hands-on leadership style, balancing strategic direction with active involvement in day-to-day quality initiatives. Prepare and execute safety validation testing in line with existing safety standards. Establish quality gates and exit criteria for releases, ensuring issues are caught early and escalated effectively. Define and implement automation frameworks that improve test coverage and reduce regression cycles across embedded, backend, and UI layers. Collaborate cross-functionally with development, product, and operations teams to drive quality throughout the development lifecycle. Track and communicate quality metrics (e.g., autonomy minutes, error rates, coverage gaps, reliability trends) to senior leadership and stakeholders. Continuously improve QA processes, tools, and infrastructure to support rapid scaling and increased product complexity. Represent QA in release reviews, incident investigations, and roadmap planning, ensuring quality considerations are built in from the start. What You'll Bring Bachelor's or Master's degree in Systems, Electrical, Mechanical, Robotics, or related engineering discipline. 7+ years of experience integrating embedded systems into complex electro-mechanical platforms (preferably off-highway, automotive, or robotics). 4+ years direct management experience, with a proven track record of growing employees and ensuring execution to company needs. Experience with system validation and verification across both lab environments and field deployments. Proficiency in Python, C/C++, or similar for test automation, diagnostics, and data analysis. Demonstrated ability to read, interpret, and implement OEM system specifications and safety standards. Familiarity with functional safety frameworks (ISO 18497, ISO 25119, or equivalent) and best practices for safe system integration. Comfortable working in fast-paced partner environments, balancing technical rigor with customer-facing collaboration. What Makes You a Strong Fit Experience in robotics, autonomous vehicles, or other complex electromechanical systems. Familiarity with hardware-in-the-loop (HIL) setups, simulation environments, or field validation processes. Experience driving compliance with safety or quality standards (e.g. ISO 18497, ISO 26262, IEC 61508, etc.). Comfortable operating at both strategic and tactical levels-setting QA vision while jumping in to debug when needed. Passion for building high-reliability systems that work in the real world. $145,000 - $180,000 a year The US base salary range for this full-time position is $145,000 to $180,000 + equity + benefits + unlimited PTO The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location, internal equity, and additional factors, including, but not limited to, job-related skills, experience, and relevant education or specialty training. Your recruiter can share more about the specific salary range during the hiring process. Benefits: 100% covered medical, dental, and vision for the employee (cost plus partner, children, or family is additional) Commuter Benefits Flexible Spending Account (FSA) Life Insurance Short- and Long-Term Disability 401k Plan Stock Options Collaborative work environment working alongside passionate mission-driven folks! Our interview process is generally conducted in four (4) phases: Phone Screen with People Operations (30 minutes) Video Interview with the Hiring Manager (45 minutes) Panel Interview (Video interviews scheduled with key stakeholders, each interview will be 30 to 45 minutes) Final Interviews (CEO, CFO, 30 minutes each)

Posted 30+ days ago

C logo
Cambia HealthPocatello, ID

$86,000 - $141,000 / year

MANAGER QA & REPORTING (HEALTHCARE) Hybrid (In office 3 days/week) within Oregon, Washington, Idaho or Utah Build a career with purpose. Join our Cause to create a person-focused and economically sustainable health care system. Who We Are Looking For: Every day, Cambia's Operations and Compliance Team is living our mission to make health care easier and lives better. The Manager of Quality Assurance And Reporting directs, develops and leads the staff accountable for providing Health Plan Operation Quality Assurance Auditing and Reporting. Accountable for the timely and accurate external corporate reporting for the Blue Cross Blue Shield Association (BCBSA) Local Operations Scorecard (LOS) and Licensee Desk Level Audit (LDLA), as well as Performance Guarantee performance measures. Responsible for the interpretation of LOS, LDLA, and PG policies and regulations and for the implementation of the necessary statistically valid audit procedures to assess these performance measures. May also be responsible for internal high dollar prepay, staff performance auditing activities, external audit support, or compliance audits. Responsible for writing audit programs, evaluating audit results, and reporting to internal Senior Management any quality issues and areas where quality improvement is needed. Primary business contacts include BlueCross BlueShield Association, affiliate Plan LOS or LDLA peers, Member and Provider Experience, Claims, Group and Member Administration, DTS, and Provider Services Division management - all in service of making our members' health journeys easier. If you're a motivated and experienced QA & Reporting Leader looking to make a difference in the healthcare industry, apply for this exciting opportunity today! What You Bring to Cambia: Preferred Key Experience: Experience with AI tools and technologies to enhance productivity and decision-making in professional settings highly desired Qualifications and Certifications: Bachelor's degree in Business, Accounting, Health Care, Management or related field Five years of experience in claims, membership, or customer service activities is desired minimum three years experience in a leadership or supervisory position Equivalent combination of education and experience Skills and Attributes (Not limited to): Ability to communicate effectively, verbally and in writing with all levels of Cambia personnel. Ability to lead and participate in a team environment to achieve department goals and objectives consistent with corporate vision and strategies. Ability to interpret regulations and external reporting requirements, plan for and successfully implement changes in LOS, LDLA, performance guarantee, and staff performance audit requirements, including appropriate sampling methodology, audit oversight, and concise and accurate reporting. Knowledge of audit techniques and statistical sampling methods and procedures including sample sizes, variances, confidence levels, random and stratified sampling, and precision levels. Knowledge of generally accepted auditing procedures and practices, obtained through an auditing course or prior work experience. Knowledge of quality tools and quality improvement methodologies. Demonstrated effective and diplomatic interpersonal skills with all levels of staff and management Demonstrated analytical ability in identifying problems, developing solutions and implementing effective courses of action. Ability to think clearly under pressure and project a professional image at all times. Strong proficiency with personal computer applications including Microsoft Excel, Word, and PowerPoint. What You Will Do at Cambia (Not limited to): Responsible for developing and implementing quality audits throughout Health Plan Operations to ensure that quality service levels are met or exceeded. Prepares and maintains reference manuals and audit programs/procedure guidelines for all Quality Assurance audits and reports. Maintains knowledge of the BlueCross and Blue Shield Association LOS Program, LDLA, and Performance Guarantee Audit measures, standards and reporting procedures. Analyze and report audit results using graphs/trending in order to highlight and prioritize quality improvement opportunities. Identify error trends and work with business areas to reduce repeat errors. Lead cross-functional quality improvement initiatives by collaborating with Claims, GMA, and Member and Provider Experience, and other divisions to implement corrective action plans. Contribute to and/or manage Quality Assurance Audit & Reporting corporate initiatives. Prepare requests for new or changes to existing audit sampling methods and procedures. Tests sampling program changes and directs implementation. Assists with the preparation of the annual budget for the department and monitors monthly operating expenses to ensure they are within budget. Facilitate regular quality review meetings with cross-functional teams to discuss findings, share best practices, and coordinate improvement initiatives. Demonstrate analytical ability in identifying problems, developing solutions and implementing an effective course of action. Help drive the resolution and completion of outstanding Corrective Action Forms (CAF) that involve repeat audit findings. Ensure hiring, performance evaluations, training and employee development promotes improved production and efficiency along with employee satisfaction. Give presentations to staff or management of various departments in such a way as to promote understanding and motivation to improve or maintain corporate performance levels. Direct and evaluate the activities of subordinates to assure work is completed in an effective accurate and timely manner. Responsible for hiring, performance evaluations, training and employee development. Optimize audit processes by leveraging technology where possible. Integrate audit findings into the training and documentation programs to drive continuous improvement. The expected target hiring range for the Mgr QA and Reporting is $92k - $124k is depending on skills, experience, education, and training; relevant licensure / certifications; performance history; and work location. The bonus target for this position is 15% . The current full salary range for this position is $86k / $141k. About Cambia Working at Cambia means being part of a purpose-driven, award-winning culture built on trust and innovation anchored in our 100+ year history. Our caring and supportive colleagues are some of the best and brightest in the industry, innovating together toward sustainable, person-focused health care. Whether we're helping members, lending a hand to a colleague or volunteering in our communities, our compassion, empathy and team spirit always shine through. Why Join the Cambia Team? At Cambia, you can: Work alongside diverse teams building cutting-edge solutions to transform health care. Earn a competitive salary and enjoy generous benefits while doing work that changes lives. Grow your career with a company committed to helping you succeed. Give back to your community by participating in Cambia-supported outreach programs. Connect with colleagues who share similar interests and backgrounds through our employee resource groups. We believe a career at Cambia is more than just a paycheck - and your compensation should be too. Our compensation package includes competitive base pay as well as a market-leading 401(k) with a significant company match, bonus opportunities and more. In exchange for helping members live healthy lives, we offer benefits that empower you to do the same. Just a few highlights include: Medical, dental and vision coverage for employees and their eligible family members, including mental health benefits. Annual employer contribution to a health savings account. Generous paid time off varying by role and tenure in addition to 10 company-paid holidays. Market-leading retirement plan including a company match on employee 401(k) contributions, with a potential discretionary contribution based on company performance (no vesting period). Up to 12 weeks of paid parental time off (eligibility requires 12 months of continuous service with Cambia immediately preceding leave). Award-winning wellness programs that reward you for participation. Employee Assistance Fund for those in need. Commute and parking benefits. Learn more about our benefits. We are happy to offer work from home options for most of our roles. To take advantage of this flexible option, we require employees to have a wired internet connection that is not satellite or cellular and internet service with a minimum upload speed of 5Mb and a minimum download speed of 10 Mb. We are an Equal Opportunity employer dedicated to a drug and tobacco-free workplace. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, age, sex, sexual orientation, gender identity, disability, protected veteran status or any other status protected by law. A background check is required. If you need accommodation for any part of the application process because of a medical condition or disability, please email CambiaCareers@cambiahealth.com. Information about how Cambia Health Solutions collects, uses, and discloses information is available in our Privacy Policy.

Posted 2 weeks ago

C logo
Cambia HealthSpokane, WA

$86,000 - $141,000 / year

MANAGER QA & REPORTING (HEALTHCARE) Hybrid (In office 3 days/week) within Oregon, Washington, Idaho or Utah Build a career with purpose. Join our Cause to create a person-focused and economically sustainable health care system. Who We Are Looking For: Every day, Cambia's Operations and Compliance Team is living our mission to make health care easier and lives better. The Manager of Quality Assurance And Reporting directs, develops and leads the staff accountable for providing Health Plan Operation Quality Assurance Auditing and Reporting. Accountable for the timely and accurate external corporate reporting for the Blue Cross Blue Shield Association (BCBSA) Local Operations Scorecard (LOS) and Licensee Desk Level Audit (LDLA), as well as Performance Guarantee performance measures. Responsible for the interpretation of LOS, LDLA, and PG policies and regulations and for the implementation of the necessary statistically valid audit procedures to assess these performance measures. May also be responsible for internal high dollar prepay, staff performance auditing activities, external audit support, or compliance audits. Responsible for writing audit programs, evaluating audit results, and reporting to internal Senior Management any quality issues and areas where quality improvement is needed. Primary business contacts include BlueCross BlueShield Association, affiliate Plan LOS or LDLA peers, Member and Provider Experience, Claims, Group and Member Administration, DTS, and Provider Services Division management - all in service of making our members' health journeys easier. If you're a motivated and experienced QA & Reporting Leader looking to make a difference in the healthcare industry, apply for this exciting opportunity today! What You Bring to Cambia: Preferred Key Experience: Experience with AI tools and technologies to enhance productivity and decision-making in professional settings highly desired Qualifications and Certifications: Bachelor's degree in Business, Accounting, Health Care, Management or related field Five years of experience in claims, membership, or customer service activities is desired minimum three years experience in a leadership or supervisory position Equivalent combination of education and experience Skills and Attributes (Not limited to): Ability to communicate effectively, verbally and in writing with all levels of Cambia personnel. Ability to lead and participate in a team environment to achieve department goals and objectives consistent with corporate vision and strategies. Ability to interpret regulations and external reporting requirements, plan for and successfully implement changes in LOS, LDLA, performance guarantee, and staff performance audit requirements, including appropriate sampling methodology, audit oversight, and concise and accurate reporting. Knowledge of audit techniques and statistical sampling methods and procedures including sample sizes, variances, confidence levels, random and stratified sampling, and precision levels. Knowledge of generally accepted auditing procedures and practices, obtained through an auditing course or prior work experience. Knowledge of quality tools and quality improvement methodologies. Demonstrated effective and diplomatic interpersonal skills with all levels of staff and management Demonstrated analytical ability in identifying problems, developing solutions and implementing effective courses of action. Ability to think clearly under pressure and project a professional image at all times. Strong proficiency with personal computer applications including Microsoft Excel, Word, and PowerPoint. What You Will Do at Cambia (Not limited to): Responsible for developing and implementing quality audits throughout Health Plan Operations to ensure that quality service levels are met or exceeded. Prepares and maintains reference manuals and audit programs/procedure guidelines for all Quality Assurance audits and reports. Maintains knowledge of the BlueCross and Blue Shield Association LOS Program, LDLA, and Performance Guarantee Audit measures, standards and reporting procedures. Analyze and report audit results using graphs/trending in order to highlight and prioritize quality improvement opportunities. Identify error trends and work with business areas to reduce repeat errors. Lead cross-functional quality improvement initiatives by collaborating with Claims, GMA, and Member and Provider Experience, and other divisions to implement corrective action plans. Contribute to and/or manage Quality Assurance Audit & Reporting corporate initiatives. Prepare requests for new or changes to existing audit sampling methods and procedures. Tests sampling program changes and directs implementation. Assists with the preparation of the annual budget for the department and monitors monthly operating expenses to ensure they are within budget. Facilitate regular quality review meetings with cross-functional teams to discuss findings, share best practices, and coordinate improvement initiatives. Demonstrate analytical ability in identifying problems, developing solutions and implementing an effective course of action. Help drive the resolution and completion of outstanding Corrective Action Forms (CAF) that involve repeat audit findings. Ensure hiring, performance evaluations, training and employee development promotes improved production and efficiency along with employee satisfaction. Give presentations to staff or management of various departments in such a way as to promote understanding and motivation to improve or maintain corporate performance levels. Direct and evaluate the activities of subordinates to assure work is completed in an effective accurate and timely manner. Responsible for hiring, performance evaluations, training and employee development. Optimize audit processes by leveraging technology where possible. Integrate audit findings into the training and documentation programs to drive continuous improvement. The expected target hiring range for the Mgr QA and Reporting is $92k - $124k is depending on skills, experience, education, and training; relevant licensure / certifications; performance history; and work location. The bonus target for this position is 15% . The current full salary range for this position is $86k / $141k. About Cambia Working at Cambia means being part of a purpose-driven, award-winning culture built on trust and innovation anchored in our 100+ year history. Our caring and supportive colleagues are some of the best and brightest in the industry, innovating together toward sustainable, person-focused health care. Whether we're helping members, lending a hand to a colleague or volunteering in our communities, our compassion, empathy and team spirit always shine through. Why Join the Cambia Team? At Cambia, you can: Work alongside diverse teams building cutting-edge solutions to transform health care. Earn a competitive salary and enjoy generous benefits while doing work that changes lives. Grow your career with a company committed to helping you succeed. Give back to your community by participating in Cambia-supported outreach programs. Connect with colleagues who share similar interests and backgrounds through our employee resource groups. We believe a career at Cambia is more than just a paycheck - and your compensation should be too. Our compensation package includes competitive base pay as well as a market-leading 401(k) with a significant company match, bonus opportunities and more. In exchange for helping members live healthy lives, we offer benefits that empower you to do the same. Just a few highlights include: Medical, dental and vision coverage for employees and their eligible family members, including mental health benefits. Annual employer contribution to a health savings account. Generous paid time off varying by role and tenure in addition to 10 company-paid holidays. Market-leading retirement plan including a company match on employee 401(k) contributions, with a potential discretionary contribution based on company performance (no vesting period). Up to 12 weeks of paid parental time off (eligibility requires 12 months of continuous service with Cambia immediately preceding leave). Award-winning wellness programs that reward you for participation. Employee Assistance Fund for those in need. Commute and parking benefits. Learn more about our benefits. We are happy to offer work from home options for most of our roles. To take advantage of this flexible option, we require employees to have a wired internet connection that is not satellite or cellular and internet service with a minimum upload speed of 5Mb and a minimum download speed of 10 Mb. We are an Equal Opportunity employer dedicated to a drug and tobacco-free workplace. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, age, sex, sexual orientation, gender identity, disability, protected veteran status or any other status protected by law. A background check is required. If you need accommodation for any part of the application process because of a medical condition or disability, please email CambiaCareers@cambiahealth.com. Information about how Cambia Health Solutions collects, uses, and discloses information is available in our Privacy Policy.

Posted 2 weeks ago

Claire's Accessories logo
Claire's AccessoriesChicago, IL

$67,704 - $90,272 / year

About the Role The Chemical Quality Assurance (QA) Associate, Beauty supports product quality, safety, and compliance across our business and partnerships. This role will support the merchant teams and suppliers to assist in documentation review and supplier quality management to ensure all beauty and personal care products meet regulatory and brand standards. Reporting to the Manager, Quality Assurance, this position plays a key role in maintaining product integrity and supporting Claire's business growth through consistent quality excellence. Key Responsibilities: Supplier Quality Management: Partner with sourcing and merchant teams to evaluate suppliers and maintain quality standards. Oversee supplier documentation, audits, and continuous improvement actions. Documentation & Regulatory Support: Maintain technical files, labeling accuracy, and compliance documentation. Support regulatory submissions and prepare quality summaries for new launches. Quality Issue Investigation: Analyze customer feedback and product trends to identify and resolve quality issues. Lead root cause analysis and manage corrective and preventive actions (CAPA). Cross-Functional Collaboration: Work with internal teams and third-party labs to align on quality, testing, and sustainability goals. Support clean beauty and product safety initiatives across categories. Other duties as assigned Education: Bachelor of Science or Engineering or a related field 5-10 years of experience in cosmetics or personal care QA/QC Experience in a multi-brand or retailer-led QA organization. Familiarity with QA testing workflows. Experience in responding to regulatory agencies such as FDA, Customs and CPSC. Knowledge of packaging materials compatibility and sustainability testing. Certification or coursework in Cosmetic Product Safety Assessment or GMP (ISO 22716) Strong understanding of cosmetic formulation, labeling, and regulatory standards. Familiar with FDA MoCRA, Health Canada and Prop 65. Experience reviewing RSLs, MSDS, CPSR, COA, and microbiological testing reports. Excellent organizational skills and ability to manage multiple workstreams across partners. Strong written and verbal communication, comfortable interacting with partners. Proficient in Microsoft Excel, SharePoint, and compliance databases.2-3 years of experience in retail operations, wholesale/franchise coordination, planning, finance, merchandising support, or similar. Compensation Range: $67,704.00 - $90,272.00 Claire's is committed to adhering to all applicable company policies and federal, state, and local laws and regulations. All positions will be compensated at or above the legally mandated minimum wage for the location in which work is performed. The final compensation will be determined by various factors such as relevant work experience, education, certifications, skills, and geographic location. Benefits for full-time employees included medical, dental, and vision insurance, voluntary welfare plans, bonus plan eligibility, 401(k) match, vacation time, sick time* and paid leave. Benefits for part-time employees included voluntary welfare plans, 401(k) match, vacation time, sick time* and paid leave in required states. Sick Time: For the State of Washington, all employees will accrue paid sick time at the rate of 1 hour for every 30 hours worked. Claire's is an equal opportunity employer committed to diversity, equity, and inclusion and we encourage applications from members of all underrepresented groups, including those with disabilities. We will accommodate applicants' needs, upon request, throughout all stages of the recruitment process. Please inform us of the accommodation(s) that you may require. Information received relating to accommodation will be addressed confidentially. To request accommodation, please email Benefits@claires.com. Only messages sent for this purpose will be considered.

Posted 4 days ago

LabCorp logo
LabCorpBurlington, NC
LabCorp is seeking a Test Automation Engineer/Jr. Software Developer to support automation efforts for it LIMS applications. This highly technical position will be responsible for identifying, planning and executing test automation activities in an Agile/Scrum environment while ensuring high quality software and ensure compliance according to regulatory statutes, policies and procedures. Create test automation scripts for UI applications, including Java/.Net/VB, Web Services/APIs and custom-designed automated solutions. Perform manual testing as needed to understand application processes and workflows in order to convert into automated test scripts. Create and maintain automated test scripts in defined repository, integrate scripts into the continuous delivery pipeline and provide output reporting for test execution runs. Manage and organize test data and perform data analysis. Develop and maintain quality repositories to assure quality data integrity, including IBM DB2, Oracle, SQL, S3 and other database platforms. Communicate QA risks, milestones, and status to the QA lead or Project Manager. Review and verify functional and system requirements to ensure project deliverables pass QA criteria. Provide work estimates for testing activities. Assist in the setup and maintenance of QA test environment and tools. Collect and report on quality statistics and metrics. Record and monitor discovered defects and QA related issues. Participate in quality related discussions. Promote continuous improvement and improve test cycle duration through the use of testing tools. Education and Experience Requirements: Bachelor's degree or equivalent in Electrical or Electronics Engineering or Computer Science. Clinical Healthcare experience a plus. 5+ years hands-on experience building test automation solutions for UI or service and/or transferrable software development experience. Self-managing with the ability to control the analysis and quality processes throughout the software lifecycle while continuously driving quality into the overall work process. Ability to project, schedule and track assigned tasks or tasks of others; able to determine scope and provide input to manage work effort, project resourcing and risks as required. Design, develop and/or implement automation for API/Service using frameworks such as RestAssure with Java or UI frameworks using Selenium with Java (TestNg, Cucumber/BDD). Experience using Gherkin language to write detailed automation test cases. Execute manual scripts and convert into automated test scripts (service and UI). Experience setting up virtualized services/automated scripts to interface with databases or other data sources. Experience testing and interfacing with middleware components such as message queue layer, ETL transfers, OSB/ESB, IIB. Summary: LabCorp is seeking a Test Automation Engineer/Jr. Software Developer to support automation efforts for it LIMS applications. This highly technical position will be responsible for identifying, planning and executing test automation activities in an Agile/Scrum environment while ensuring high quality software and ensure compliance according to regulatory statutes, policies and procedures. Create test automation scripts for UI applications, including Java/.Net/VB, Web Services/APIs and custom-designed automated solutions. Perform manual testing as needed to understand application processes and workflows in order to convert into automated test scripts. Create and maintain automated test scripts in defined repository, integrate scripts into the continuous delivery pipeline and provide output reporting for test execution runs. Manage and organize test data and perform data analysis. Develop and maintain quality repositories to assure quality data integrity, including IBM DB2, Oracle, SQL, S3 and other database platforms. Communicate QA risks, milestones, and status to the QA lead or Project Manager. Review and verify functional and system requirements to ensure project deliverables pass QA criteria. Provide work estimates for testing activities. Assist in the setup and maintenance of QA test environment and tools. Collect and report on quality statistics and metrics. Record and monitor discovered defects and QA related issues. Participate in quality related discussions. Promote continuous improvement and improve test cycle duration through the use of testing tools. Education and Experience Requirements: Bachelor's degree or equivalent in Electrical or Electronics Engineering or Computer Science. Clinical Healthcare experience a plus. 5+ years hands-on experience building test automation solutions for UI or service and/or transferrable software development experience. Self-managing with the ability to control the analysis and quality processes throughout the software lifecycle while continuously driving quality into the overall work process. Ability to project, schedule and track assigned tasks or tasks of others; able to determine scope and provide input to manage work effort, project resourcing and risks as required. Design, develop and/or implement automation for API/Service using frameworks such as RestAssure with Java or UI frameworks using Selenium with Java (TestNg, Cucumber/BDD). Experience using Gherkin language to write detailed automation test cases. Execute manual scripts and convert into automated test scripts (service and UI). Experience setting up virtualized services/automated scripts to interface with databases or other data sources. Experience testing and interfacing with middleware components such as message queue layer, ETL transfers, OSB/ESB, IIB. Experience implementing automated capabilities on various platforms (Mainframe- MUMPs, Cache, VB, .NET, Java, etc.). Experience building custom automated solutions (java programs, scripts, etc.) that interface/simulate lab instrumentation/equipment. Software development: coding skills on various platforms (Java/J2EE, .NET, VB, Unix scripting, etc.). Software development: Experience in Java Servlets, JSP, EJB (session Beans and Message Driven Beans), JMS, JDBC, Frameworks (Struts, spring, Hibernate, JSF) in Implementing web based and enterprise solutions. Service Oriented Testing Tools (ReadyAPI/SOAP NG, XML WSDL testing). Back end validation of DB platforms (DB2, Oracle, Big Data/Hanna, SQL Server, etc.). Experience working with AWS/S3 technology. Provide peer support, Production support during normal or off-hour timeframes. General skills (required): Bachelor's degree (or higher) or equivalent in Electrical or Electronics Engineering, Computer Science. 5-7 years hands-on Automation or Development experience. Experience using both Agile and Waterfall testing methodologies. Must be able to work independently in the absence of supervision. Experience automating various application types (mainframe, web-based, client/server, COTS, services, etc.). Technical skills: Programming Languages: Java, C/C++, Python, VB/VB Script Automation tools: Selenium, Cucumber/Gherkin, TestNg, Jenkins/CICD pipeline integration Test Management Tools: JIRA, ALM/Quality Center, TFS, GIT, Confluence Development Tools: IntelliJ, Eclipse, Visual Studio, UFT/QTP Database: Oracle, DB2, Big Data Platforms (Hanna, Hadoop), S3, Elastic Search Indexes, SQL/MySQL Test Methodologies: Agile, Waterfall, Hybrid Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.

Posted 3 days ago

T logo
Tanium Inc.Durham, NC

$95,000 - $290,000 / year

The Basics: Tanium QA Engineers are responsible for testing products built on the Tanium platform. This will involve working with developers and product managers to construct & execute test plans, plan for functional, performance & regression testing, file detailed bugs, and provideding visibility through project updates. Strong technical skills are essential. You should be comfortable installing and configuring a variety of operating systems in virtual environments, configuring networks for those systems, and then installing and configuring software on those systems. You should be comfortable reading and understanding product requirements and translating those into test cases and test labs. If these things sound as exciting to you as they do to us, then Tanium could be your new home! What you'll do: Utilize project management and leadership skills to effectively manage multiple concurrent projects throughout the entire software development cycle Author and execute test plans and test cases Manage resources, project plans, estimates and timelines Review test plans, monitor test progress, and distribute test reports Understand business requirements and develop test cases against them Understand and apply effective product test strategies Build and manage product test labs that consist of virtual machines running a variety of operating systems Work with source code repositories and CI/CD systems (GitHub preferred) Offer input on the role of QA in the software development lifecycle (SDLC). Analyze and offer input on product requirements We're looking for someone with: Education Bachelor's Degree in Computer Science, IT or other relevant degree or equivalent experience Experience 5+ years of Quality Assurance/Testing experience (enterprise level preferred) Solid understanding of manual and black box testing experience Solid understanding of operating systems (Linux & Windows preferred); how they are installed and configured, and now MacOS Strong experience with virtualization - VMware, Hyper-V, UTM, and similar Proficient with scripting languages - shell, Python, PowerShell, etc., and familiar with their use for streamlining day to day tasks Solid understanding of networking, experience in using packet capture tools is a plus (Wireshark, TCP Dump, etc) Must be familiar with terms like authentication, file signature, and certificates Experience with testing RESTful APIs Project management skills a plus. About Tanium Tanium delivers the industry's only true real-time cloud-based endpoint management and security offering. Its platform is real-time, seamless, and autonomous, allowing security-conscious organizations to break down silos between IT and Security operations that results in reduced complexity, cost, and risk. Securing more than 32M endpoints around the world, Tanium's customers include Fortune 100 organizations, top US retailers, top US commercial banks, and branches of the U.S. Military. It also partners with the world's biggest technology companies, system integrators, and managed service providers to help customers realize the full potential of their IT investments. Tanium has been named to the Forbes Cloud 100 list for nine consecutive years and ranks on the Fortune 100 Best Companies to Work For. For more information on The Power of Certainty, visit www.tanium.com and follow us on LinkedIn and X. On a mission. Together. At Tanium, we are stewards of a culture that emphasizes the importance of collaboration, respect, and diversity. In our pursuit of revolutionizing the way some of the largest enterprises and governments in the world solve their most difficult IT challenges, we are strengthened by our unique perspectives and by our collective actions. We are an organization with stakeholders around the world and it's imperative that the diversity of our customers and communities is reflected internally in our team members. We strive to create a diverse and inclusive environment where everyone feels they have opportunities to succeed and grow because we know that only together can we do great things. Each of our team members has 5 days set aside as volunteer time off (VTO) to contribute to the communities they live in and give back to the causes they care about most. What you'll get The annual base salary range for this full-time position is $95,000 to $290,000. This range is an estimate for what Tanium will pay a new hire. The actual annual base salary offered may be adjusted based on a variety of factors, including but not limited to, location, education, skills, training, and experience. In addition to an annual base salary, team members will receive equity awards and a generous benefits package consisting of medical, dental and vision plan, family planning benefits, health savings account, flexible spending account, transportation savings account, 401(k) retirement savings plan with company match, life, accident and disability coverage, business travel accident insurance, employee assistance programs, disability insurance, and other well-being benefits. For more information on how Tanium processes your personal data, please see our Privacy Policy

Posted 30+ days ago

I logo
INCOG BioPharmaFishers, IN
Working closely with the QA Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Associate will need to provide support with identifying operational and quality gaps. The Quality Assurance Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Associate will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Associate will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Associate will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. Essential Job Functions: Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor. Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc. Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations. Support other QA personnel with batch record reviews, material release, etc. Prioritize and coordinate his/her time in balancing production timelines with product quality assurances. Exercise 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 or escalate the issue to Manager for resolution. Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. Ability to manage multiple projects in a fast-paced environment. Special Job Requirements: This position will support primarily second shift (3 pm to 11:30 pm) with occasional weekend support, dependent on operations' needs. Bachelor's Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.) Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment. Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc.. Understanding of Good Documentation Practices (GDPs) and its criticality. Excellent written and verbal communication skills. General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: Hands-on experience with aseptic manufacturing, inspecting finished products, and Acceptable Quality Limits (AQLs). Experience with Continuous improvement, Six Sigma, and/or Lean principles. 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 5 days ago

U logo
United Therapeutics CorporationRaleigh, NC
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 You bring a wealth of Quality Assurance knowledge to the table and are eager to build and grow a QA team around you. You're able to pivot at a moment's notice between utilizing your individual expertise and mentoring or developing a member of your team. The Associate Director, QA Engineering will provide advanced support and subject matter technical expertise and utilize industry best practices to maintain cGMP compliance for UTC combination products, clinical materials supply, and new product development of active pharmaceutical ingredients (API), drug substances, drug products, and combination product/medical devices. This role will manage and support the new product development activities through product and process development and improvement, implementation of product/process verification, validation activities, and commercialization. Responsibilities for this role also include oversight and leadership of the Change Control, Quality Event, and CAPA programs and supporting management during regulatory agency(ies) inspections, third-party partners, and customer audits. Work independently and as part of a multi-functional team to manage, lead, and prioritize workloads, complex projects/tasks, departmental initiatives, and deadlines Manage quality engineering input and provide advanced technical expertise to processes and manufacturing documentation, including complex data analysis, material specifications, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested and that compliance to quality systems procedures, regulations, and standards are achieved Support the trending and reporting of CAPA activities. Lead investigations and serve as an internal expert for Risk Assessments, Quality Events, Investigations, Out of Specifications (OOS), Change Controls, Exceptional Conditions, and Corrective and Preventive Action (CAPA) processes for GxP events Interact regularly with peers and senior management across multiple functional groups (e.g., Research and Development, Manufacturing, Validation, Regulatory Affairs, etc.). Negotiate and manage expectations across functional groups for project timelines and quality requirements Lead and manage quality engineering activities and provide SME support for project start-up and the technology transfer of new products or methods into existing manufacturing operations. Responsible for evaluating new technologies against applicable guidance, and industry practices Provide support during external, internal, and health agency audits Author, collaborate, analyze, and approve cGxP related documents (i.e., product/ design specifications, computerized systems, validation protocols and reports (IOQ/PQ), analytical/microbiological method validations, stability protocols, operational protocols and reports, Site Master Files, DHF, DMR, etc.) for accuracy, completeness, and compliance with cGMP and UTC policies, procedures, and requirements Participate in supplier selection process and specification reviews as necessary Participate in, and/or lead, quality system, process and product-related decisions. Recommend and manage changes to policies and establishes procedures affecting immediate function/group Collaborate with different members of the QA/RA departments working on special projects Manage, lead, and support quality system project initiatives and continuous process verification. Through continuous oversight, identify gaps and coordinate resolution, and quality improvement initiatives Coordinate and lead internal mock audits in preparation of the site readiness for health agency inspections Mentor peers on technical information on projects, mock audits and recalls, and other areas of expertise Direct and manage team to include responsibilities for goal setting, performance reviews/management, coaching, mentoring and career development For this role you will need Minimum Requirements Bachelor's Degree in engineering, chemistry, biology, biochemistry, or related scientific discipline or Master's Degree in engineering, chemistry, biology, biochemistry, or related scientific discipline 12+ years of experience in quality assurance, quality engineering and management in the FDA regulated environment or a related industry with Bachelor's degree or 10+ years of experience in quality assurance, quality engineering and management in the FDA regulated environment or a related industry with Master's degree 5+ years of experience leading multi-discipline engineering projects with previous participation in regulatory inspections Ability to manage, mentor, and/or provide technical guidance to other engineers/project team members Clear understanding and application of QA and cGMP principles, concepts, industry practices, and standards Able to work independently and as part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines Demonstrated expertise with FDA Quality System regulations and cGMP, ISO 13485, ISO 14971, ISO 10993, IEC 60601, IEC 62304, 21 CFR Part 11, 210, 211, and 820 Clear understanding of US FDA, EU, and JP GMP regulations Knowledge of software validation practices and data integrity initiatives Familiarity with pharmaceutical operations (i.e., aseptic filling, etc.), solid oral dose, biologics operations, medical devices, and combination products Strong technical writing skills Strong experience in regulatory inspections Strong computer skills and demonstrated competence to include MS Office applications, database applications, and spreadsheet in a network environment Able to work independently with occasional to no need for guidance Strong organizational skills and strong attention to detail Preferred Qualifications Strong experience with validation and facility qualification Experience in process development activities for manufacturing/ assembly operations Knowledge of Laboratory Information Management System (LIMS), Systems Application and Product (SAP), MasterControl, MiniTab, Trackwise, and Empower software systems Continuous Process Validation experience Knowledge of software validation practices and data integrity initiatives Job Location United Therapeutics requires this candidate to be 100% on-site at our Durham, NC locations. 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 30+ days ago

Niagara Bottling logo
Niagara BottlingTemple, TX
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 Technician Lead Responsible for executing corporate and plant specific Food Safety, Quality and Laboratory requirements. The QA Technician Lead reports to QA Supervisor. In the absence of the Quality Assurance Technician Lead, the QA Supervisor or designate will assume the job duties. Essential Functions Ensure all parameters of food safety and quality are being adhered to and maintained throughout the facility. Assist with batching chemicals/ingredients for production. Calibrate lab and line equipment for accurate results. Collect in-process and finished product samples. Conduct standardized qualitative and quantitative testing to ensure it meets specifications. Perform aseptic testing for microbial contamination. Follow protocols for documenting testing results. Recognize deficiencies and initiate proper follow-up. Identify and isolate product that does not meet standards. Aid in troubleshooting deficiencies and non-conformances. Review food safety and quality records. Actively participate in plant teams (HACCP, Safety, etc.) Conduct other duties as assigned by management. 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: 4 Years- Experience in Field or similar manufacturing environment 4 Years- Experience in Position 4 Years- Experience managing people/projects experience may include a combination of work experience and education Must read, write and communicate in English. Must be able to work 12-hour shift (days or nights) on a rotating schedule Must follow GMP Policy - wear company issued shirt, hat, safety glasses, earplugs and hairnet in production areas. Able to lift up to 50 lbs. Able to work under pressure in a very fast paced environment Preferred Qualifications: 6 Years- Experience in Field or similar manufacturing environment 6 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 Makes safety the number one priority Keeps alert for safety issues and escalates immediately Effectively prioritizes tasks based on department goals Shows respect to others and confronts interpersonal issues directly Prioritizes resolution of customer issues effectively Responds promptly and honors commitments to internal and external customers InnovACT Makes recommendations to continuously improve policies, methods, procedures, and/or products Demonstrates adaptability by reacting appropriately to unexpected changes in situations or circumstances Increases performance through greater efficiency Find a Way Seeks to develop technical knowledge through learning from other experts Understands interdepartmental impact of individual decisions and actions Seeks solutions rather than placing blame Empowered to be Great Consistently looks for ways to improve one's self through growth and development opportunities Communicates clearly and promptly up, down, and across Communicates effectively to manage expectations Education Minimum Required: High School Diploma Preferred: Associate's Degree Certification/License: Required: HACCP, PCQI Preferred: Better Process Control Certification Foreign Language Required: Full Professional Proficiency 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 TEMPLE

Posted 30+ days ago

DRB Systems logo
DRB SystemsAkron, OH
DRB Systems ("DRB"), an operating company of Vontier, is the leading provider of technology-enabled devices and software solutions to the North American car wash industry. The QA Engineer Intern is responsible for running multiple projects supporting DRB product line. JOB PURPOSE: Do you desire a hands-on experience in quality assurance engineering where you play a critical role in research on hardware under test? Do you enjoy collaborating with other parts of the business to enhance virtualization for components and resiliency testing? If this sounds like you, then join us as an Quality (QA) Engineering Intern Intern at DRB. This position reports to a QA leader and is in Green, OH. ESSENTIAL FUNCTIONS & RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each of these essential functions at a satisfactorily level. Other essential and non-essential functions may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Develop new skills and build professional relationships with friendly, experienced co-workers. Receive guidance from supervisors, mentors, and subject matter experts that will guide you in succeeding in your role and discovering your ideal career. Collaborate and assist team with structured engineering research on current hardware under test Work with cross functional teams for virtualization of applicable components Develop test scripts and growing resiliency testing suite, where applicable Foster analytical skills to drive impact on overall business objectives. Develop, manage, and execute specific projects with defined deliverables. Deliver an end-of-project presentation to the DRB senior leadership team. MINIMUM REQUIREMENTS: A rising Junior - Senior level student pursuing a degree in Computer Science, electrical engineering or related field. Strong data and system analysis skills Strong communication skills. Ability to interact with cross-functional teams. Self-motivated and results-oriented. Available to work 3 days in Green, OH. (2 days are remote) Hybrid role is Monday through Friday, 40 hours per week Strong analytical and problem-solving ability Knowledge or experience with Azure DevOps, Jira or other software development platforms is a plus Vontier (NYSE: VNT) is a global industrial technology company uniting productivity, automation and multi-energy technologies to meet the needs of a rapidly evolving, more connected mobility ecosystem. Leveraging leading market positions, decades of domain expertise and unparalleled portfolio breadth, Vontier enables the way the world moves - delivering smart, safe and sustainable solutions to our customers and the planet. Vontier has a culture of continuous improvement and innovation built upon the foundation of the Vontier Business System and embraced by colleagues worldwide. Additional information about Vontier is available on the Company's website at www.vontier.com. The company in which you have expressed employment interest is a subsidiary or affiliate of Vontier Corporation. The subsidiary or affiliate is referred to as "Vontier Company". Vontier is proud to be an equal opportunity employer. We strive to build inclusive environments and ensure equitable access, opportunity, and treatment for all. Vontier does not tolerate discrimination and harassment of any kind based on race, color, national origin, religion, ancestry, sex (including pregnancy, childbirth, and related medical conditions), age, sexual orientation, marital status, disability, veteran status, citizenship status, gender identity or expression, gender information and any other characteristics protected by law. We make hiring decisions based on your experience and skills. Vontier is committed to providing reasonable accommodations for qualified individuals with disabilities. If you need assistance or an accommodation in the application or interview process, you may contact us at e-mail vnttalentacquisition@vontier.com. Equal Opportunity Employer

Posted 1 week ago

Lonza, Inc. logo

Manager, QA Compliance & Validation

Lonza, Inc.Bend, OR

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Job Description

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.

Lonza Pharma & Biotech is looking for a Manager, Compliance & Validation to join the Quality Assurance team in Bend, OR. This role provides an outstanding opportunity to lead an exceptional QA team in a company that values innovation and collaboration. Join us and help drive the future of life sciences forward!

Key Responsibilities:

  • Provide assistance in internal audits, audits from external parties, and regulatory inspections of designated Quality Management Systems as the QA subject matter expert.
  • Maintain current knowledge of applicable regulations, mentorship, and standards, and train personnel on cGMPs and applicable regulations.
  • Participate in compliance evaluation of regulated activities within pharmaceutical development and cGMP manufacturing.
  • Report to management any departures from regulations and cGMP noted during the assessment of manufacturing operations, internal audits, supplier audits, external audits, and regulatory inspections. Help in identifying necessary CAPA and validate the successful execution and efficacy of assigned measures.
  • Develop efficient workflows and processes, and appropriate metrics to track compliance, efficiency, and efficiency.
  • Manage and supervise designated aspects of the Quality Assurance and Management System.
  • Ensure procedures, systems, and processes are effective and meet regulatory requirements and business needs.
  • Supervise QA staff at various levels responsible for lifecycle management of quality system documents.
  • Review and approve regulatory documents.
  • Perform other duties as assigned.

Key Requirements:

  • Bachelor's Degree or equivalent experience required.
  • Significant experience in the pharmaceutical/biotech industry.
  • Compliance and Regulatory experience required.
  • Prior Management experience required.
  • GMP (Good Manufacturing Practices) experience preferred.
  • Strong leadership, writing, and communication/presentation skills are required.
  • Must be independent, self-motivated, organized, able to multi-task, and skilled in communication, facilitation, and collaboration.
  • Individual must be a great teammate prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

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.

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