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KBI Biopharma logo
KBI BiopharmaDurham, North Carolina
Position Summary: We are seeking a highly motivated QA Manufacturing Specialist I/II at our state-of-the-art commercial manufacturing facility in Patriot Park, Durham, NC. You will have the unique opportunity to help build our site processes and culture as we ramp up to full manufacturing capacity. We embrace KBI’s values of learning and growth, high standards, collaboration, and trust and respect to solve problems and continuously improve. As a center of excellence, our site enables real-time quality and process monitoring through paperless records with integrated automation. We are looking for a critical thinker who is comfortable tackling new challenges / unknowns and utilizing a risk-based approach. We hope you join us! Position Responsibilities: Be an on-the-floor quality partner working with the manufacturing team during operations Work with manufacturing and other groups to escalate and resolve deviations and other compliance issues Conduct QA walkthroughs Participate in safety walkthroughs Participate in process improvements Attend relevant meetings in support of manufacturing operations Review electronic batch records and logbooks Provide feedback on facility response for unplanned events Other tasks and projects as assigned Work 12-hour shifts (2-2-3 schedule, day shift) Position Qualifications: MQA Specialist I High School diploma or equivalent. Degree progression preferred. GMP / regulated industry / laboratory experience is required (approximate 1-3 years). Demonstrated ability to work in a team environment. Demonstrated ability to understand the manufacturing process. Ability to perform routine core MQA responsibilities. MQA Specialist II Associate degree / bachelor’s degree strongly preferred or appropriate years of experience (approximate 3-5 years). Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization. Demonstrated ability to represent Quality on interdepartmental meetings. Demonstrated knowledge of technical documents. Ability to support internal and external audits. Demonstrated ability to train employees on Quality subjects. Ability to track and trend department metrics Salary Ranges: MQA Specialist I: $54,000 - $74,300 MQA Specialist II: 66,966 - 92,077 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 30+ days ago

University Home Care logo
University Home CareLivonia, Michigan
University Home Care is looking for a skilled Registered Nurse with Quality Assurance experience in the homecare and/or hospice setting to join our team in Livonia, MI. Conduct quality assurance checks on patient care plans and documentation. Ensure compliance with all regulatory requirements. Develop and implement quality improvement initiatives. Provide training to staff on quality assurance measures. Active RN license in the state of Michigan. Prior experience in Quality Assurance in homecare and/or hospice. Strong knowledge of regulatory requirements in homecare/hospice. Excellent communication and organizational skills. Competitive salary. Health and dental insurance. Paid time off. 401(k) retirement plan. University Home Care is a leading provider of homecare services in the Livonia, MI area. We are committed to providing high-quality care to our patients and ensuring a positive work environment for our employees. We have 2 positions available.One position that is full-time.Salary requires you to visit patients in the field for home care.Ann hospice in Wayne, Oakland and mccombnaughey's.The other position is for part time contractor

Posted 30+ days ago

Baxter logo
BaxterIrvine, California
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your Role At Baxter: Responsible for endorsing process and product quality, efficacy, and safety through the routine assessment of plant operations and finished products. Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products. Your team When you join the Quality team you belong to a group that never shies away from a challenge and truly believes that teamwork makes jobs great. Motivated by work that is never the same from one day to the next, this team powers through internal processes to create products that they deeply believe in. Individuals within the quality organization are encouraged to think strategically about how to best-solve any issues at hand. Baxter remains positive, confident, and resilient as it approaches new challenges and strives to create the best possible product for the client, always. What You'll Be Doing Perform all tasks as QM Lab Technician with minimal supervision Arrange and Conduct dose audits of final product with Vendor and Carrier. Initiate and investigate exceptions/OOLs/NCR, through TrackWise. Perform laboratory and manufacturing audits as required. Update plant SOPs as required. Participate in functions involving teams, which impact production, increase efficiency, tackle problems, generate cost savings, and improve quality. Support improvement projects Receiving purchased media and supplies. Preparation and sterilization of reagents and media, including growth promotion of media. Sterilize tools and glassware for lab testing. Collecting test samples in clean rooms and utility rooms. Monitor the cleanroom environment (checking non-viable air quality, assessing viable air quality, evaluating viable surface conditions) Monitor the environment of key systems like the compressed air and nitrogen system (non-viable and viable air) Perform various laboratory tests on final product (bioburden and endotoxin testing) Maintain data integrity and ensure compliance with company SOPs and specifications. Documentation of tests on controlled forms or LIMS and maintain accurate and complete quality records. Perform equipment maintenance as scheduled. What You'll Bring Knowledge of GMP documentation and FDA required. Demonstrated attention to details and accuracy required. Must have good communication skills. General knowledge of quarantine and warehouse operation helpful. May be required to work flexible hours and overtime on short notice. Experience in a pharmaceutical or Biotech industry helpful Familiarity with cGMP and FDA requirements preferred. Bachelors Degree in science-related field with 0-2 years relevant experience OR Associates degree in science-related field with 1-3 years of relevant experience OR Highschool Diploma/GED with 5+ years of relevant experience We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $60,000 to $75,000. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .

Posted 2 days ago

Rivers Agile logo
Rivers AgilePittsburgh, PA
We are seeking a QA Engineer with strong testing fundamentals and a working understanding of embedded systems to validate end-to-end functionality, reliability, and robustness of the system. You’ll be the first line of defense against bugs in an embedded C++ codebase, helping us catch issues early and iterate rapidly. Location: Our office is in the northern part of the Pittsburgh metro area. As the product you’re testing involves both hardware and software, this position requires onsite work with the ability to work from home occasionally. Candidates must be local or willing to relocate. Description This role emphasizes hands-on testing, lightweight infrastructure setup, and collaborative issue resolution. You’ll work closely with developers to validate device features, file clear and actionable bugs, and retest fixes. The ideal candidate is an analytical engineer who thrives in a fast-moving, hardware-adjacent environment and is comfortable getting hands-on with devices, logs, and simple test utilities like custom Python scripts.You’ll quickly get up to speed on system architecture, set up lightweight test tools, and collaborate with developers to define a concise, high-impact test plan. Your focus will be on hands-on testing of smart devices and gateways, validating command-response behavior, reporting clear and actionable bugs, and verifying fixes. You'll also assist with basic scripting, maintain test documentation in Testrail, and contribute to test summary reports that help guide product quality decisions. Qualifications 7+ years of professional experience in software QA or test engineering Strong understanding of QA fundamentals including test planning, test case authoring, execution, and bug reporting Experience testing systems that interact with hardware such as IoT devices, firmware-driven systems, or embedded Linux environments Familiarity with embedded concepts such as microcontrollers, UART, I2C, SPI, and state machines Comfortable working in Linux environments like Ubuntu Core with the ability to navigate logs, monitor processes, and use command-line tools to validate device behavior Understanding of communication flows between devices and the cloud using protocols like MQTT Familiarity with basic Python scripting to support test utilities, automation, or data logging Experience using test case management tools such as TestRail and issue trackers like Jira Strong written communication skills for documenting bugs, test cases, and test results Detail-oriented and self-directed with the ability to thrive in a fast-paced development cycle Pluses Experience testing embedded C or C++ firmware running on microcontrollers Familiarity with Microchip’s ARM Cortex-M0+ MCUs and development tools like MPLAB X and PICkit Exposure to hardware-in-the-loop testing or validating physical device behavior in real time Ability to read basic circuit diagrams or understand sensor behaviors such as proximity, pressure, or motion Experience capturing and analyzing serial communication traffic Comfort building lightweight test harnesses or utilities in Python for embedded systems testing Package: salaried position, bonus program, full benefits (medical, dental, vision, supplementary), holidays, paid time off, paid parental leave, 401(k) plan, good work-life balance, and work-from-home options Powered by JazzHR

Posted 2 weeks ago

Holtec International logo
Holtec InternationalCovert, MI
Quality Assurance Auditor Holtec Decommissioning International (HDI) is currently seeking a Quality Assurance Auditor to join the Palisades Nuclear Plant team in Covert, MI.   We are proud of our reputation for professional and technical excellence, and we recognize that the key to upholding that reputation resides in the excellence of our employees. We are looking for talent who brings value to the organization and contribute in advancing our business and reputation.  Palisades Nuclear Power Plant may soon become the first nuclear power plant in the United States to restart after previously entering the early stages of decommissioning. By joining our team, you will be part of a unique and historic undertaking for the industry and the nation. JOB SUMMARY/PURPOSE Plans, coordinates, leads, performs and documents QA oversight activities, which include audits, surveillances, observations, reviews and performance analysis.  JOB DUTIES/RESPONSIBILITIES Develops audit plans, performs audits, and leads audit teams.   Ensures quality and accuracy of QA documentation. Supports the QA organization with the roll up of issues to identify adverse trends.   Reviews site and department performance and, based on performance and risk insights, selects areas for surveillance and selects plant activities for observation if required.   Effectively communicates with all levels of station personnel.   Is familiar with current nuclear QA practices, codes, standards, regulations and nuclear plant work processes.   Exercises stop work authority over non-conforming production and engineering activities that present a significant risk to plant equipment and/or personnel.   MINIMUM REQUIREMENTS Minimum education required of the position Bachelor’s degree in Engineering or a technical field or equivalent work experience.   Minimum experience required of the position Four years of nuclear power plant experience in the field of quality assurance or supervisory experience in plant operations. Requires minimum one year of experience in the overall implementation of the Quality Assurance Program and ANSI/ASME N45.2.23-1978 certification.   Minimum knowledge, skills, and abilities required of the position Knowledge of Nuclear and other regulatory quality / QAPM requirements. Knowledge of nuclear industry regulations and experience. Strong written and verbal communication skills. Proficient in the use of Microsoft desktop applications. Strong analytical and problem solving skills. Ability to manage multiple assignments. General understanding of nuclear power operations. Strong leadership skills.   Any certificates, licenses, etc., required for the position Lead Auditor Certification   HDI offers its employees a robust rewards package which includes: a competitive salary; a broad benefits package including medical/RX, dental, vision, life, disability, hospitalization and other valuable voluntary options; time-off programs; 401(k) with employer match; professional and career development opportunities; and an unmatched culture focused on client-service, quality, and tireless pursuit of excellence in all we do. HDI is an equal opportunity, drug-free employer committed to diversity in the workplace. EOE/Minorities/Females/Vet/Disability. Powered by JazzHR

Posted 30+ days ago

CSpring logo
CSpringSpringfield, IL
Description Do you thrive on digging into complex data systems, automating the tedious, and ensuring nothing escapes your quality radar? We're on the hunt for a meticulous, technically savvy, and forward-thinking Quality Analyst (QA) to join our team and support a large-scale data warehouse initiative. This is not your average QA role - you'll be the critical link between cutting-edge data platforms, robust automation frameworks, and AI-driven testing strategies. We're looking for someone who's not afraid to roll up their sleeves, lead the charge in automation, and elevate quality standards in a fast-paced, collaborative Agile environment. You'll be instrumental in designing and executing automated and manual tests, ensuring seamless integration, and leveraging Generative AI for smarter, faster testing. What You'll Do: Be a champion for quality - participate in walk-throughs, inspections, reviews, and user group meetings to drive excellence. Design, prioritize, and execute test cases with a sharp eye for detail, reporting bugs with precision. Perform rigorous regression testing after every code update. Build automated tests using BDD & TestNG frameworks, executing them via Selenium, Cucumber, and Java. Embed quality engineering practices within a modern CI/CD pipeline, integrating version control, test management, and automation tools. Collaborate closely with Scrum teams - groom user stories, define acceptance criteria, and ensure business needs are fully met. Conduct end-to-end testing: functional, integration, regression - you'll own it all. Document test results thoroughly and communicate findings with technical clarity. Dive deep into data architecture - Databricks, Snowflake, Azure Synapse - and ensure test coverage aligns with platform intricacies. Leverage AI-based tools to auto-generate test cases, create test data, and perform API testing. Utilize Generative AI to craft user stories and streamline test case development. Requirements 5+ years of accomplished experience in software testing, 5+ years of prior experience working as Backend/ Database/ EDW/ ETL tester, 4+ years of excellent SQL skills and experience working with any one RDBMS (Teradata, SQL, etc.), 4+ years of experience in user-interface, smoke, end-to-end (E2E) and integration testing 4+ years of strong troubleshooting and reasoning skills; the ability to debug and resolve difficult technical problems, 4+ years of excellent test design skills and experience working with any one Test Management tool Ability to travel to Springfield, Illinois up to three times per year Preferred Qualifications: Healthcare domain experience (commercial, Medicaid and Medicare claims data, EDI X12 transactions in the healthcare industry?(999, 837, 834, 277) or HL7), Experience with DevOps, Informatica PowerCenter Tools Knowledge: Selenium with java, Cucumber (BDD), SOAP UI, Postman, RestAssured, HP ALM, Jira, Github, Experience working in a CI/CD environment like Jenkins for executing automated tests, application deployment, Experience working with complex XML/JSON, EDI X12, SQL transactions, Good knowledge on Automation framework preparation / usage, Strong communication collaboration and influencing skills to drive change Located within driving distance to Springfield, IL Ready to Elevate Software Quality? If you're a QA who loves automation, data platforms, and cutting-edge testing strategies, we want to meet you. Apply now and be part of a team where your expertise drives innovation and excellence.

Posted 30+ days ago

Fortis Construction Inc logo
Fortis Construction IncCheyenne, WY
Job Description: As the QA/QC Engineer, you will be responsible for ensuring that all construction projects meet quality standards and comply with applicable codes and regulations. QA/QC Engineers must be able to work collaboratively with project team members and managers to develop and maintain relationships with owners, vendors, suppliers, and other project stakeholders to project quality standards. A successful QA/QC Engineer must be detail-oriented, innovative, creative, proactive, and be able to manage and resolve conflict. The QA/QC Engineer is responsible for the implementation of the project quality control program. This includes QA/QC functions, procedures, and controls within the organization as well as ensuring performance of daily QA/QC responsibilities to ensure proper coordination and construction that meet project standards and requirements. The QA/QC Engineer will review project documentation and inspection schedules to ensure coverage and compliance are met. QA/QC Engineer is responsible for attending inspections, issuing reports, and the collecting documentation issued by inspectors and files the required Quality Records. Responsibilities Review construction plans, specifications, and documentation to ensure compliance with quality standards. Participate in pre-installation meetings to verify that each trade partner is prepared to be compliant of the project's QC requirements before beginning work on site. Coordinate with project managers, contractors, and other stakeholders to ensure that quality standards are met throughout the construction process. Monitor QA/QC program effectiveness and work to continuously improve the project quality control program, as needed. Prepare, review, and distribute quality specific Request for Information (RFIs), submittals, and other contract documents in a timely manner; ensure compliance with the contract documents. Monitor the construction process to identify and resolve any issues that could affect quality or safety. Provide recommendations and solutions to improve the quality and safety of construction projects. Monitor construction activities and review materials and equipment delivered to the project for adherence to specifications. Coordinate and participate in field inspections to verify that work is proceeding with contract documents, approved submittals, and industry regulations. Maintain accurate records of all inspections, tests, checklists and other quality-related activities. Conduct regularly scheduled QA/QC meetings, review deficiency logs, punch lists, etc., provide documentation and meeting minutes. Conduct training sessions for construction workers and other stakeholders on quality standards, safety regulations, and other relevant topics. Assist in other duties as assigned, relevant to the achievement of the position's and team's objectives. Required Qualifications Ability to work and effectively communicate with the project team, trade partners, consultants, and owner representatives. Must be proficient with a variety of related computer software applications including MS Office (Excel, Outlook, Project, Word) and PDF programs. Must be proficient with a variety of related computer software applications including MS Office. Familiarity with a broad range of general construction processes and testing protocols and procedures. Familiarity with governing specifications including ASTM, ANSI, ACI, etc. related to construction testing and inspection procedures and processes. Ability to read and understand construction plans and specifications. Excellent organization skills including methodical and detail-oriented to ensure project QC documentation is complete and procedures are adhered to ensuring issues are closed and project risks are mitigated. Bachelor's degree in construction management, engineering or equivalent combination of training and experience. 1-3 years of construction experience of similar scale and capacity. Have a general knowledge of civil, architectural, mechanical, and electrical work. Ability to work independently and as part of a team. Ability to work in a fast-paced environment. Must possess a valid driver's license and a satisfactory driving record in accordance with Fortis policy. Preferred Qualifications Bachelor's degree in a related field is preferred. Experience in the construction industry with related role is preferable, but not required. Certified Quality Engineer (CQE) preferred but not required. Physical Requirements Stand or walk for extended periods of time while conducting site inspections and monitoring construction activities. Climb ladders or stairs to access various areas of the construction site. Lift or move equipment, tools, or materials weighing up to 50 pounds. Work in outdoor environments in various weather conditions. Wear appropriate personal protective equipment (PPE) such as hard hats, safety glasses, work boots, and high visibility vests. Distinguish colors and perform visual inspections of construction materials, structures, and equipment. Sit for extended periods of time while reviewing construction plans, specifications, and other documents, either hard copy or on the computer. Travel Requirements All Fortis positions require some level of driving. The above description is intended to identify the essential functions and requirements for the performance of this job; it is not to be construed as a complete statement of duties, responsibilities or requirements. All jobs require behaviors consistent with our Core Values and Culture. The employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations could be made to enable employees with disabilities to perform the essential functions of the role, absent undue hardship. Fortis Construction, Inc. reserves the right to revise the job description at any time. RQ-0343 QA/QC Engineer (Open) Fortis is an Equal Employment Opportunity employer. We adhere to a policy of making employment decisions without regards to race, color, religion, sex, age, disability or any other protected categories. It is our intention that all qualified applicants be given an equal opportunity and that selection decisions be based on job-related factors.

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: Sep 10, 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: QA, Quality Assurance, Testing, Medical Device, QA Engineer, Quality, Technology, Healthcare, Engineering

Posted 30+ days ago

Gilead Sciences, Inc. logo
Gilead Sciences, Inc.Foster City, CA
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Key Responsibilities: Perform a wide variety of activities to ensure compliance with applicable regulatory requirements. Participate in the development of Standard Operating Procedures (SOPs) to meet quality objectives. Maintain routine programs and processes to ensure high-quality products and compliance with GMP and GLP standards. Review manufacturing, environmental monitoring, and quality control data for in-process and finished products. Work directly with operational teams to ensure inspections, statistical process control analyses, and audits are conducted regularly to enforce requirements and meet specifications. Participate in writing annual product reviews and developing training programs related to quality product production. Lead or coordinate investigations and corrective and preventive action (CAPA) recommendations for manufactured products. Collaborate with Research and Development during new product start-ups and identify checkpoints for new products and processes. Work independently on routine tasks and receive general instructions for new assignments. Basic Qualifications: BS degree with 4+ years of relevant experience in a GMP-related field, or MS degree with 2+ years of relevant experience. Working knowledge of GMPs and/or GLPs. Familiarity with quality assurance systems, methods, and procedures. Knowledge of FDA/EMEA standards and quality systems. Basic understanding of Six Sigma, LEAN, and root cause analysis tools. Strong audit, investigation, and report writing skills. Good verbal, written, and interpersonal communication skills. Proficiency in Microsoft Office applications. Preferred Qualifications: Prior experience in the pharmaceutical industry. Experience supporting regulatory inspections and quality audits. Ability to work independently and collaboratively in a cross-functional environment. Strong organizational and planning skills. The salary range for this position is: $102,085.00 - $132,110.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

Posted 1 week ago

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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 6 days ago

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Sony Playstation NetworkLos Angeles, CA
Why PlayStation? PlayStation isn't just the Best Place to Play - it's also the Best Place to Work. Today, we're recognized as a global leader in entertainment producing The PlayStation family of products and services including PlayStation5, PlayStation4, PlayStationVR, PlayStationPlus, acclaimed PlayStation software titles from PlayStation Studios, and more. PlayStation also strives to create an inclusive environment that empowers employees and embraces diversity. We welcome and encourage everyone who has a passion and curiosity for innovation, technology, and play to explore our open positions and join our growing global team. The PlayStation brand falls under Sony Interactive Entertainment, a wholly-owned subsidiary of Sony Group Corporation. Join the award-winning team that created God of War Sony Santa Monica Studio is looking for QA Leads to support our internal projects on the PS5 platform. The QA Lead is responsible for the facilitation of direct development team support, operational title gameplay test planning, execution, advancement, organization, coverage, execution and communication for their assigned projects. The general purpose of this job is to provide a technically proficient, dedicated resource that is completely focused on the direct operational oversight of all internal and external title QA operational testing services for their assigned project(s), to provide effective test support, efficient test execution and accurate test results to development and production teams. This role also includes the facilitation of internal production for QA, as well as leadership of our external partnerships with our SIE and 3rd party vendor support services related to testing. An in-depth comprehension of the Santa Monica Studio development pipeline, tools, development team structure, workflows and production mindset are foundational to this role. Attention to detail is a critical requirement of the role, as is a highly communicative, amicable, adaptable, growth-minded and mature demeanor in supporting the development team. We value those that have a mindset of OWNERSHIP, diligence in their CRAFTSMANSHIP, a commitment to PARTNERSHIP and humility in their LEADERSHIP. In turn, we will work alongside you to craft an environment that empowers and equips you with the freedom to create better, the autonomy to think better, the opportunity to grow better and the feedback to choose to "Be Better". Responsibilities The effective planning, administration, execution and communication of QA Master Test Plans and the effective incorporation of them into the software development process The administration and communication of all QA related project data and associated risks for all assigned projects The operational training, development, and delegation to assigned Assistant Leads, Sr Test Analysts and Testers The managing of developer support requests and efficiently balancing them with our day-to-day test services The balancing of tactical day to day responsibilities with the need to advance, refine and implement new QA processes and systems to further drive test service effectiveness, efficiency, accuracy and overall value The consistent modeling of all core SMS values in support of the SMS Mission and Vision The consistent modeling of all core SMS QA expectations and job profile competencies The learning and in depth understanding of the development team structure, discipline workflows and discipline roles The learning and in depth understanding of the SMS software development cycle and core development tools The facilitation of communication and QA support directly with the production and development teams Ownership of the development, tasking and execution of all operational testing for assigned projects Ownership over managing of project databases for assigned titles Partnering with assigned Assistant Leads regarding establishing an efficient relationship with clear areas of responsibility between them that is aligned with the SMS QA Team Expectations Partnering with the production and development team in supporting and collaborating work across disciplines to help effectively drive the project to completion Partnering with QA Sr Managing Producer, in the operational performance management of assigned Assistant Leads, Sr Test Analysts and Testers Requirements Responsible, strong work ethic, self-motivated and pro-active Minimum of 3 years in Senior Test Analyst or equivalent position in development integrated role Successfully shipped at least 2 AAA titles on current generation console platforms and/or PC Successfully completed certification and application of ISQTB Foundation and Intermediate Level CTAL Demonstrated knowledge of Software Development Lifecycle Demonstrated knowledge of build authoring pipeline, processes, and systems Demonstrated ability to thrive in a high pressure, high workload environment balancing multiple responsibilities Demonstrated knowledge of test case design well as advanced QA/QC methods Demonstrated knowledge of QA and game development systems, tools, and database utilization Demonstrated knowledge and experience with advanced testing and automation methods Demonstrated knowledge and experience with Maya, Jenkins, Perforce and other common software development tools Demonstrated knowledge and experience authoring wiki in confluence content for technical and non-technical audience Demonstrated knowledge and experience with 3rd party test and support services remote management Demonstrated knowledge of all current PlayStation development and retail hardware Demonstrated knowledge of all current PlayStation platform SDK's and debug tools Demonstrated knowledge of TestFlo, TestRail, or equivalent test management software Demonstrated knowledge of Jenkins or equivalent automation testing tools and languages Demonstrated experience leading, coaching and mentoring staff, both technically and behaviorally Demonstrated knowledge of and maturity in emotional intelligence Exceptional organizational skills Exceptional written and verbal communication skills Excellent critical analysis and problem-solving skills Excellent gameplay skills and multi-genre experience Passion for video games Preferred Experience BS Cognitive Science, Computer Science, Communications, BA in Project Management, Business Intelligence, or QA related field Successfully completed, certification and application of SQE Mastering Test Design Foundation Level Demonstrated knowledge of PlayStation Studios QA Operations processes, systems and workflows Successful completion, certification and application of ISQTB Advanced Level CTAL Successful completion, certification and application of PMI CAPM Demonstrated knowledge of SMS game development applicable programming and scripting languages, such as Dart, Java, JavaScript, C, C#, C++, and Python Expertise in and familiarity with Agile techniques, including Kanban and SCRUM Expertise in QA/QC analytics Expertise in remote team management #LI-SMS #LI-MC1 Please refer to our Candidate Privacy Notice for more information about how we process your personal information, and your data protection rights. At SIE, working with our partners, we consider several factors when setting each role's base pay range, including the competitive benchmarking data for the market and geographic location. Please note that the individual base pay range may vary based on job-related factors which may include knowledge, skills, experience, and location. In addition, this role is eligible for benefit offerings that include medical, dental, and vision. Click here to learn more. The estimated base pay range for this role is listed below, this is an hourly rate. $34.24-$50.99 USD Equal Opportunity Statement: Sony is an Equal Opportunity Employer. All persons will receive consideration for employment without regard to gender (including gender identity, gender expression and gender reassignment), race (including colour, nationality, ethnic or national origin), religion or belief, marital or civil partnership status, disability, age, sexual orientation, pregnancy, maternity or parental status, trade union membership or membership in any other legally protected category. We strive to create an inclusive environment, empower employees and embrace diversity. We encourage everyone to respond. PlayStation is a Fair Chance employer and qualified applicants with arrest and conviction records will be considered for employment.

Posted 30+ days ago

Broadridge logo
BroadridgeStockholm, ME
At Broadridge, we've built a culture where the highest goal is to empower others to accomplish more. If you're passionate about developing your career, while helping others along the way, come join the Broadridge team. Who we need We're seeking a Senior QA Engineer to ensure the quality, reliability and scalability of complex software systems across the full SDLC. You will lead test strategy and automation, operate and optimize testing environments, and collaborate closely with Engineering, Product, Client Services, Compliance and Operations to deliver high-quality releases at speed. We are looking for talented, self-motivated individuals with a desire to learn, build deep expertise and create impact working collaboratively. Our associates embrace change, easily integrate and succeed in a fast-paced global environment. If you believe you have what we are looking for, we invite you to be part of our global network of talented, client-focused, forward-thinking teams where your contributions will be recognized, and rewarded, helping you to progress your career You will be part of our Broadridge Trading and Connectivity Solutions (BTCS)' engineering team, creating high performance multi-asset trading platforms that automate the entire front office for investment banks and brokers. Responsibilities Design, develop and maintain comprehensive test plans for complex systems, ensuring high-quality product releases Build, maintain and expand automated regression test suites - including integration with CI/CD pipelines - using the following automation frameworks/programming languages: Python, Pytest, C++ Take ownership of setting up and maintaining scalable and stable testing environments Communicate progress, risks and issues to management and engage with stakeholders across business, technology, compliance and operations Create and maintain technical documentation, such as test strategies, automation guides and environment setup manuals, to ensure ongoing system supportability Work with the Development, CS and Product team on Root Cause Analysis of the escaped defects Champion and actively contribute to best practices in QA processes Mentor junior QA team members, sharing expertise in automation, tools and testing methodologies Requirements 6+ years of hands-on experience in software quality assurance with at least 4 years in automation development Experience working with bug tracking and test management tools Ability to operate both independently and collaboratively within a distributed global team Ability to handle context switching on multiple projects Excellent analytical and problem-solving skills, with attention to details Strong written and spoken English Able to take ownership and accountability for tasks, and to plan work so as to achieve the best outcome and most impact In-depth knowledge of software testing lifecycles, requirements analysis and test plan creation and execution Expertise in automation framework or programming language (e.g. Python, Pytest, C++), including designing and implementing robust automated test suites Knowledge of financial markets, financial asset types and exchange connectivity protocols will be considered a plus Hands-on experience with version control systems (e.g., Git, Gerrit) Knowledge of Linux and command-line proficiency Bachelor's degree in STEM (Computer Science, Math, Physics or related field) from a recognized institution Hybrid Flexible at Broadridge: We are made up of high-performing teams that meet in person to learn and collaborate as needed. This role is considered hybrid, which means you'll be assigned to a Broadridge office and given the flexibility to work partially remotely. #LI-Hybrid #LI-LM1 We are dedicated to fostering a collaborative, engaging, and inclusive environment and are committed to providing a workplace that empowers associates to be authentic and bring their best to work. We believe that associates do their best when they feel safe, understood, and valued, and we work diligently and collaboratively to ensure Broadridge is a company-and ultimately a community-that recognizes and celebrates everyone's unique perspective.

Posted 3 weeks ago

KBI Biopharma logo
KBI BiopharmaDurham, NC
Position Summary: This individual supports all QA activities related to Facility Engineering and Validation in a contract manufacturing organization (CMO) setting. Execute QA review and approval of documentation to result in timely oversight of equipment, computer systems, utilities, and facilities to support start-up of a new commercial manufacturing programs and subsequent routine operations. This individual provides quality oversight of facility upgrades and expansions. This position will focus on supporting the computer system validation process as well as implementing a site data integrity program for pharmaceutical systems. QA experience in cGMP operations dealing with CSV and DI initiatives is required. Position Responsibilities: Leads implementation of site Data Integrity initiative and provides governance to ongoing DI initiatives. Perform QA review and approval of computer system validations, including for electronic batch records, manufacturing process control system, instrumentation and other CSV items. Provides quality support for Engineering, Validation and IT activities including both clinical and commercial operations in a contract manufacturing organization (CMO) setting. Works directly with Validation and Facilities Engineering to review and approve GMP documentation developed to support the delivery of key capital projects and facilitate the ongoing lifecycle management defined by the Validation program. Provide quality oversight of Validation activities supporting commercial operations in a contract manufacturing organization (CMO) setting. Works directly with Validation to review and approve GMP documentation developed to support the commercial manufacturing facility and facilitate the ongoing lifecycle management defined by the Validation program. In conjunction with team and Validation functional areas, develops and manages all validation policies, procedures, and protocols. Works to continuously improve and streamline the validation processes. Supports the site change control system. Works directly with functional areas to review and approve change controls. Reviews change controls and assesses for Quality Impact. Works to continuously improve and streamline the change control system Provides general QA support for Facilities Engineering, Validation, Metrology, AFS, Manufacturing and IT departments, which includes review and approval of Change Controls, Calibration Alert Notifications, Gemba Walks, etc. Support process improvement projects to include streamlining and improving the lifecycle of CSV/DI initiatives and site review process. Able to react to change productively and handle other essential tasks as assigned. Position Requirements: BS and 5+ years of experience or MS and 3+ years of experience (QA Specialist I/II) / BS and 8+ years of experience or MS and 5+ years of experience (QA Senior Specialist) in a QA role in a cGMP regulated environment within biopharmaceuticals or equivalent. Experience with computer system validation (CSV), Data Integrity (DI) and qualification of enterprise systems is required Working knowledge of FDA, EU and ROW cGMP regulations is required. Must demonstrate strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills. Experience in a commercial manufacturing environment is beneficial. Experience with computer validation and/ or qualification of enterprise systems is required. Salary Range: $84,000 - $115,000 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com. KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 3 weeks ago

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Element Solutions Inc.Itasca, IL
Long Description MAES MacDermid Alpha Electronics Solutions, a business of Element Solutions Inc (NYSE:ESI), is renowned worldwide for its commitment to revolutionizing the electronics industry. With a legacy spanning over a century, we have continually set new benchmarks for excellence, reliability, and sustainability in electronic materials. Our Expertise: Wafer Level Solutions: Revolutionizing wafer fabrication processes for enhanced efficiency and performance. Semiconductor Assembly Solutions: Driving innovation in semiconductor assembly processes for unparalleled reliability. Circuitry Solutions: Tailored solutions to meet the dynamic demands of modern circuitry. Circuit Board Assembly Solutions: Elevating circuit board assembly processes for optimal performance. Film & Smart Surface Solutions: Transforming electronics with cutting-edge materials and technologies for enhanced functionality and reliability. Across diverse sectors including automotive, consumer electronics, mobile devices, telecom, data storage, and infrastructure, MacDermid Alpha Electronics Solutions has earned the trust of manufacturers worldwide. Our comprehensive range of high-quality solutions and technical services covers the entire electronics supply chain, empowering businesses to thrive in today's competitive landscape. We strive to embody the five "Elements of our Culture," our "5Cs": Challenge, Commit, Collaborate, Choose and Care. These core values are the foundation of our organization which our employees embrace in their interactions with customers, colleagues and other stakeholders to drive financial performance and create a rewarding work environment. Who are we looking for? The QC Technician is responsible for performing routine inspections and tests on products and materials to ensure they meet established quality standards. This role involves documenting and reporting inspection results, including any deviations from specifications, and assisting in the development and implementation of quality control procedures. The technician will collaborate closely with production and engineering teams to address and resolve quality issues, maintain and calibrate testing equipment and instruments, and participate in root cause analysis and corrective action processes. Additionally, the QC Technician ensures compliance with all customer and regulatory requirements. What will you be doing? The QC Technician plays a key role in ensuring product and material quality by performing routine inspections and tests to verify compliance with established standards. This position is responsible for documenting and reporting inspection results, noting any deviations from quality requirements, and assisting in the development and implementation of quality control procedures. The technician works collaboratively with production and engineering teams to address and resolve quality-related issues, maintains and calibrates testing equipment and instruments, and actively participates in root cause analysis and corrective action processes. In addition to ensuring compliance with customer and regulatory requirements, the QC Technician supports continuous improvement initiatives aimed at enhancing product quality and operational efficiency. Who are You? Associate's degree in Quality Assurance, Engineering, or a related field. Minimum of 3+ years of experience in quality assurance or a closely related role. Solid understanding of quality control methodologies and tools. Exceptional attention to detail and a high level of accuracy. Proficient in using quality management software and related tools. Strong communication and interpersonal skills. Demonstrated ability to work independently as well as collaboratively within a team environment. We understand that not all candidates may meet the requirements listed above. If you believe you have the knowledge and experience necessary to excel in this role, we encourage you to apply. What competencies will you need? Certification in Quality Assurance (e.g., Certified Quality Technician- CQT) is a plus. Strong attention to detail and a detail-oriented mindset. Self-starter with the ability to take initiative and work proactively. Must be able to communicate clearly and concisely, both verbally and in writing, with business fluency in English. Team-oriented and able to collaborate effectively in a multi-departmental environment. We are Offering... Challenge Yourself and Impact the Future- As part of our team here, as well as receiving a competitive base salary, you will also participate in a generous performance related bonus plan. In addition, you will also receive a 401k plan with company matching, Life Insurance, and Medical Insurance as well as 9 holidays. Innovative- At ESI, we are committed to solving the complex and evolving needs of our customers through innovation and high-quality standards. We are focused on bringing cutting edge and environmentally sustainable solutions to the market. Our people are the critical resource required to make that happen. We support your success by creating a strong, inclusive culture, competitive total rewards, and an appropriate work-life balance. Socially Responsible- We care about what you care about. We respect the individual differences that make up our unique expanding organization. We prioritize both sustainability and social impact in both our business operations and our local communities through our various ESI Cares initiatives and the ESI Foundation. There are many ways to get involved from employee network groups that support your interests and sense of belonging to paid volunteer days. Rewarding Performance- We are a performance driven culture where every individual has the opportunity to contribute through their actions and judgment. We strive to reward those who choose excellence through both recognition and compensation. Those who demonstrate good judgement, positive attitude, solid work ethics and ambitious objectives will see their responsibilities grow along with their compensation. The typical base salary range for this position is between $53,988 and $80,982. Long Description Equal Opportunity Employer Section content, to edit press enter. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Nearest Major Market: Chicago

Posted 2 weeks ago

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Wagstaff, Inc.Spokane, WA
Description Wagstaff manufactures equipment for aluminum producers, who process formed aluminum into parts and products you use every day. Pay: $30- $39.98 per hour, depending on experience As an employee of Wagstaff, you'll enjoy: Paid non-working holidays Monthly, site-wide BBQs Up to 8% retirement contribution Annual bonus program 1200 Sqft onsite gym, accessible 24/hrs a day Family-friendly, company-wide events To view our full benefits summary, please visit https://www.wagstaff.com/Wagstaff/Careers.htm Want to learn more about Wagstaff AT? Visit https://www.WagstaffAT.com Job Summary As a Quality Professional on Wagstaff's Quality Assurance team, you will play a crucial role in upholding our reputation for precision and quality. If you are experienced in conducting dimensional, weld and NDE inspections and you are ready to take your career to the next level, join Wagstaff's growing team of Quality Assurance Technicians! In this role, you'll use your experience and skill set to conduct inspections using a variety of precision tools and technologies that have a direct impact on project success at Wagstaff. Your attention to detail and excellent communication skills will contribute to your interactions with co-workers, auditors, customers, suppliers, and visitors, as well as continuous improvement and problem-solving activities. Primary Job Responsibilities Perform weld and NDE (VT/PT/MT/UT) inspections on various stainless steel weldments and fabricated equipement Inspect and report on materials, services, processes, and products using measuring instruments and techniques to ensure conformance with the company's quality standards Enter data and maintain paper and electronic quality records where required Participates in problem solving and continuous improvement projects Represent Wagstaff when interacting with auditors, customers, suppliers and visitors Communicate with customers and suppliers on quality-related issues as directed by the Quality Assurance Manager Prepare inspection sheets Collect, monitor, organize, report, and distribute data as it relates to quality functions of Wagstaff Prepare and present reports Assist with specialized inspections as it correlates with individual certifications. Abide by company policies In order to achieve business objectives, work weeks in excess of 40 hours may be required Other duties as assigned Requirements High school diploma or GED required Candidates must have at least 2 years of dimensional and weld inspection experience or 4 years of trade experience in fabrication, welding, or machining. Ability to read blueprints and mechanical inspection skills, experience/training in Geometric Dimensioning and Tolerance (GD&T) Candidates must have vision capable of reading a Jaeger Number 1 or equivalent type and size letter at no less than 12 inches (natural or corrected vision). Candidates cannot be color blind Candidates must be physically able to perform inspections in a manufacturing environment, including the operation of overhead cranes, jibs, and forklifts, after undergoing company training Proficient in the use of Microsoft Office business software Detail-oriented, accurate, and thorough Preferred candidate qualifications: Current AWS Certified Weld Inspector (CWI) with NDE Level II credentials (VT/PT/MT/UT) or the ability to quickly acquire NDE Level II credentials with company-provided training. Experience with AWS D1.1 & 1.6 and ASME Section VIII & B31.3 weld inspections highly desirable. Experience with stainless fabrication highly desirable. Working Environment While performing the duties of this job, work is performed primarily in an adequately lit, well ventilated, climate controlled general office environment. Close computer work is regularly required. The work usually involves minimal physical exertion. The noise level in the general office environment is usually moderate. This job may require occasional or more frequent interaction with employees on the manufacturing shop floor. While on the shop floor, the employee may be exposed to fumes, airborne particles, toxic or caustic chemicals, risks of moving equipment and parts, and other risks associated with a manufacturing environment. Because of this environment and associated risks, coordination with shop floor managers/employees may be necessary before entering the shop floor, and use of job appropriate personal protective equipment and clothing is required on the shop floor. The noise level on the shop floor is often loud. Employment at Wagstaff is dependent on successfully passing a company-paid drug screening and background check upon hire. Benefits eligibility is subject to the terms and conditions of the applicable policies, plans and programs of Wagstaff. Wagstaff is 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, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws. PM22

Posted 30+ days ago

Perplexity AI logo
Perplexity AIBelgrade, MT
Perplexity is an AI-powered answer engine founded in December 2022 and growing rapidly as one of the world's leading AI platforms. Perplexity has raised over $1B in venture investment from some of the world's most visionary and successful leaders, including Elad Gil, Daniel Gross, Jeff Bezos, Accel, IVP, NEA, NVIDIA, Samsung, and many more. Our objective is to build accurate, trustworthy AI that powers decision-making for people and assistive AI wherever decisions are being made. Throughout human history, change and innovation have always been driven by curious people. Today, curious people use Perplexity to answer more than 780 million queries every month-a number that's growing rapidly for one simple reason: everyone can be curious. Perplexity AI is looking for an experienced QA Engineer to join our small team revolutionizing the way people search and interact with the internet. You will be responsible for building and expanding the Perplexity Android app. The ideal candidate should have strong QA skills, an interest in search and large language models, and a passion for delivering a great UX backed by a quality UI. Responsibilities Testing a performant native Desktop and Android app that millions of users around the world enjoy using. Work closely with product teams to implement novel mobile/desktop experiences. Work closely with design teams to help to design fast and intuitive UI/UX. Collaborate with desktop and mobile dev teams to instrument, analyze, and improve the end-to-end experience. Work with infrastructure, backend and frontend teams on deployment processes, including testing, release, and monitoring. Requirements 4+ years industry experience Expertise in Hand Testing Expertise in Autotest frameworks Understands how to test performance and speed issues Comfortable working with a small, fast-moving team, must be willing to dive in and take ownership A passion for shipping Our cash compensation range for this role is $60,000 - $90,000. Final offer amounts are determined by multiple factors, including, experience and expertise, and may vary from the amounts listed above. Equity: In addition to the base salary, equity may be part of the total compensation package. Benefits: Comprehensive health, dental, and vision insurance for you and your dependents. Includes a 401(k) plan.

Posted 30+ days ago

Smithfield Foods, Inc. logo
Smithfield Foods, Inc.Orange City, IA
If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub. A great job-and a great future-awaits you at Smithfield Foods. We are an American food company with a leading position in packaged meats and fresh pork products. We're looking for motivated people who want to join our team and grow lasting and meaningful careers with us. Apply Now! Your Opportunity As part of our FS/QA team, you would conduct routine sanitation checks, ensuring that HAACP and USDA regulations are strictly enforced. Providing technical expertise to track product from start to finish, and develop corrective actions when needed. You will be responsible for ensuring that we are able to safely deliver the best Smithfield, Eckrich, Nathan's Famous, or any of our product brands to customers and consumers. Responsible for managing the Plant Food Safety and Quality Assurance Department to provide safe, high quality products that meet customer expectations. This role has the overall accountability of ensuring the food safety system is properly written, validated, documented and implemented as directed to ensure USDA and FDA regulatory compliance and the production of safe and wholesome products. Is accountable for the plant's Quality System and must provide solid leadership to achieve company, plant, and department goals through various management, evaluation and improvement skills and strategies that improve overall quality and profitability. The Plant Food Safety and Quality Assurance Manager reports to the Plant Manager, the Corporate Food Safety Manager and the Corporate Quality Assurance Manager. Core Responsibilities Quality and Food Safety Verification and Compliance Verifies that all Food Safety, Quality Assurance and Regulatory programs are functioning as designed, being followed and correctly documented - thus ensuring the facility has the "regulatory evidence" required to prove they have produced safe and wholesome products. Ensures USDA regulatory compliance by making scientifically defendable decisions that do not result in unjustified decreases in operational productivity or efficiency. Able to quickly and thoroughly investigate a product/process failure, determine the root cause and take prompt corrective actions; while minimizing product exposure and production down time. Revise and update food safety and quality programs and procedures as directed. Accountable for the preparation and the execution of USDA daily verification tasks, as well as numerous 3rd party audits and USDA food safety system assessments. Takes appropriate corrective action as a result of any findings generated. Develops and fosters a strong working relationship with the USDA. Food Safety and Quality Improvement Prevents HACCP, SSOP and process or product failures by working with Food Safety and Quality Assurance staff members and Operations to drive continuous improvement of product quality through developing food safety and quality plans, process controls, attention to process and specifications, food safety and quality training. Sanitation and Food Safety Accountable for the overall design of the facility's sanitation program. Including authoring a written USDA regulatory program, sanitation performance tracking, training of applicable facility production and meeting regularly with the USDA to discuss sanitation findings. Ensures that operational and pre-operational sanitation is acceptable. Implements and develops necessary verification activities including micro sampling to verify the effectiveness of sanitation activities. Takes action in response to negative micro and Shelf Life data to drive improvement. Manages daily activities, in-depth training and development of the Food Safety and Quality staff members. Document corrective actions and follow-up as necessary and conduct GMP and Sanitation audits. Executes response to negative micro and Shelf Life data to drive continuous improvement, by auditing and scrutinizing the level of equipment cleanliness prior to the start of operations. SQF Creates and maintain SQF Quality Plan. Completes reassessments of SQF Quality Plan if: Addition or removal of processing steps. Introduction of new product with processing steps not in currently included in Quality Analysis At a minimum SQF Quality Plan is reassessed annually. Oversees the development, implementation, review and maintenance of the SQF System, including food safety fundamentals outlined in 2.4.2, the food safety plan outlined in 2.4.3 and the food quality plan outlined in 2.4.4; Takes appropriate action to maintain the integrity of the SQF System. Communicates to relevant personnel all information essential to ensure the effective implementation and maintenance of the SQF System. Personnel Management Responsible for managing performance plans/reviews, work schedules and assignments of other food safety staff members. Absence In the absence of key personnel the employee's supervisor or qualified designee (one that has been trained in the key employee's duties) is responsible to complete or delegate the completion of all required tasks and responsibilities. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. Bachelor's degree from an accredited four-year college or university and 5+ years' experience in the food industry; or equivalent combination of education and experience. Minimum of 2+ years' experience in a position of leadership to include team development and management, required. Knowledge and understanding of quality assurance principles, food science and meat processing, SPC and statistics; preferred. In-depth understanding of microbiological testing and limited chemistry testing. Knowledge of various pathogens and microbes associated with food production. Hands on experience conducting microbiological testing of meat and poultry products. Comprehensive knowledge of USDA, FSIS, HACCP, and SSOP requirements. USDA/HACCP Certified, preferred. SQF Certified Expert, preferred. Ability to uphold regulatory, company and customer standards. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Knowledge of Database software; Inventory software; Manufacturing software; Spreadsheet and Word Processing software; QMS system and SAP. Excellent oral and written communication skills. Strong decision making and problem solving skills. Excellent planning and organizational skills with demonstrated multi-tasking and project management skills. Must be able to travel up to 10% of the time. May be required to work long hours and weekends. Must have the ability to complete required applicable forms in English, which requires the ability to read and write in English. Ability to work well with others in fast paced, dynamic environment. Ability to be respectful, approachable and team oriented while building strong working relationships and a positive work environment. Supervisory Provides leadership and guidance to employees in the Food Safety and Quality Assurance Department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and assisting in providing appropriate resolutions. Work Environment & Physical Demands The work environment characteristics and physical demands 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. Office and plant setting. The plant environment will include wet or humid conditions (non-weather related), extreme cold and heat (non-weather related), working near moving mechanical parts, exposure to fumes or airborne particles, and chemicals. Occasionally lift and/or move up to 50 pounds Specific vision includes close vision, distance vision, and ability to adjust focus. Frequently required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. Noise level in the work environment is usually moderate but can be loud when in the production area. IndSPR-Ops Relocation Package Available Yes EEO Information Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law. If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.

Posted 30+ days ago

NICE Systems logo
NICE SystemsAtlanta, GA
At NiCE, we don't limit our challenges. We challenge our limits. Always. We're ambitious. We're game changers. And we play to win. We set the highest standards and execute beyond them. And if you're like us, we can offer you the ultimate career opportunity that will light a fire within you. So, what's the role all about? As the Lead QA Engineer, you will play a pivotal role in shaping the quality vision across NICE's flagship product suite. You will define strategic quality goals, align them with business objectives, and lead cross-functional initiatives that drive measurable improvements in product reliability, customer satisfaction, and engineering efficiency. How will you make an impact? Serve as the quality leader for an entire domain and be accountable for the product quality Actively track the domain's quality tasks, analyze the testing needs, and define QA activities and ownership Continuously analyze and challenge existing testing coverage Plan, develop, and oversee execution of test strategy across domain Lead Quality assurance efforts that align with product objectives to ship products rapidly and with confidence Define and communicate strategic quality KPIs; monitor and act on insights to drive continuous improvement. Ensure quality is embedded throughout the SDLC, from planning and requirements to deployment, through clear acceptance criteria, regression impact analysis, and automated testing practices. Standardize, implement and evolve QA processes to get effective test coverage and scale testing efforts across our products Partner with product, engineering and DevOps teams to leverage automation for scalable solutions to prevent regression defects and ensure reliability of product Plan and lead NFR testing Define guidelines and quality led best practices for our engineering groups Coordinate cross-organization/cross-region testing activities Mentor and guide QA leaders and engineering managers to foster a culture of ownership, accountability, and continuous improvement in quality. Have you got what it takes? Education: BSc in Computer Science/Software Engineering or equivalent Requirements Minimum 3 years QA leadership experience: Team leader/Manager Minimum 5 years of Experience as a QA engineer with at least 4 years of automation experience Extensive experience designing tests for an enterprise SW solution Leadership, coordination abilities and the ability to influence without authority Ability to define QA processes across development groups Hands on experience with CI/CD and Test-Driven Development Excellent communication skills (written and verbal) and interpersonal skills Experience with full software development lifecycle using Agile Development methodology Superior analytical and problem-solving abilities Strong self-motivation; Excellent work ethic, dependable and responsible What's in it for you? This is a high-impact leadership role for someone passionate about driving quality at scale, influencing engineering culture, and delivering exceptional customer experiences. Join an ever-growing, market disrupting, global company where the teams - comprised of the best of the best - work in a fast-paced, collaborative, and creative environment! As the market leader, every day at NICE is a chance to learn and grow, and there are endless internal career opportunities across multiple roles, disciplines, domains, and locations. If you are passionate, innovative, and excited to constantly raise the bar, you may just be our next NICEr! About NiCE NICE Ltd. (NASDAQ: NICE) software products are used by 25,000+ global businesses, including 85 of the Fortune 100 corporations, to deliver extraordinary customer experiences, fight financial crime and ensure public safety. Every day, NiCE software manages more than 120 million customer interactions and monitors 3+ billion financial transactions. Known as an innovation powerhouse that excels in AI, cloud and digital, NiCE is consistently recognized as the market leader in its domains, with over 8,500 employees across 30+ countries. NiCE is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, age, sex, marital status, ancestry, neurotype, physical or mental disability, veteran status, gender identity, sexual orientation or any other category protected by law.

Posted 30+ days ago

Five Below, Inc. logo
Five Below, Inc.Philadelphia, PA
At Five Below our growth is a result of the people who embrace our purpose: We know life is way better when you are free to Let Go & Have Fun in an amazing experience, filled with unlimited possibilities, priced so low, you can always say yes to the newest, coolest stuff! Just ask any of our over 20,000 associates who work at Five Below and they'll tell you there's no other place like it. It all starts with our purpose and then, The Five Below Way, which is our values and behaviors that each and every associate believes in. It's all about culture at Five Below, making this a place that can inspire you as much as you inspire us with big ideas, super energy, passion, and the ability to make the workplace a WOWplace! POSITION SUMMARY The Engineering team, organized by product groups, is responsible for the architecture, design, development and operations of all systems and applications supporting Five Below's Retail footprint. Accordingly, we have Merchandising and Inventory Management, Planning and Allocation Accounts Payables and Corporate Finance, Stores and Omni, Logistics, BI and Data Platform, Ecommerce Engineering and Tools. Five below systems and applications supporting business functions are a combination of enterprise solutions and custom software built to create a seamless experience for our customers, driven by data assets and Infrastructure at its epicenter. Digital engineering organization is responsible for creating world class customer experience through the ecommerce website, mobile app and multiple marketplaces for the Five Below customers. The Senior Software Engineer, {Quality Assurance, Digital}, will split their responsibilities between creating and executing a testing strategy across digital and leading a high performing onshore and offshore team to ensure we meet the needs of our business while staying in budget and developing the roadmap for our future platform. Job Responsibilities: Provide technical leadership and direction to a global QA team (6-10 engineers) focused on test automation, regression testing, and release readiness Implement and evangelize best-in-class test automation frameworks (UI, API, backend, performance, mobile, mobile web) Mentor engineers across development and QA, fostering a culture of high standards, accountability, and continuous improvement Partner with product managers, developers, DevOps, and UX teams to ensure high-quality delivery Define, monitor, and improve automation coverage, defect rates, and release quality KPIs Oversee global QA resource planning, task allocation, and coordination across time zones Drive improvements in CI/CD pipelines, versioning strategies, and test data management Identify opportunities for tech debt reduction, test efficiency, and tooling upgrades Develop code, scripts, and designs per business requirements when needed. Participate in Agile rituals -daily standups, iteration planning, story huddles, retrospectives, creation of burn up chart's inceptions, document technical work in technical stories using JIRA board, and estimate (using agile points/story sizing techniques) the work effort required to complete those stories. Collaborate with product and system teams to ensure thorough test coverage and identify areas for process enhancement. Analyze and report on test outcomes, including results, challenges, and risks, even when reviewing others' work. Collaborate closely with the operations team to conduct root cause analysis on intricate challenges, ensuring a thorough understanding and resolution. Assesses and analyses release components for input to release scheduling and ensuring proper change control is documented and followed. Qualifications: Bachelor's or master's degree in computer science or equivalent 8+ years of hands-on experience in QA and Test automation as part of a high-performance engineering team in e-commerce. Strong backend development experience (e.g., Node.js, Java, Python) and frontend experience (React, Next.js preferred) Proven experience leading teams, including QA engineers across multiple geographies (onshore, nearshore, offshore) Deep understanding of test automation strategies and frameworks such as Selenium, REST Assured, etc. Experience with Commerce Tools, Shopify, or other headless commerce platforms Hands-on experience with Next.js for building performant, SEO-optimized applications Familiarity with performance and load testing tools (e.g., k6, JMeter) Working knowledge of monitoring and observability tools like Datadog, New Relic, or Grafana Experience managing or integrating outsourced QA teams and vendors Proficiency in Agile methodologies and distributed team collaboration Knowledge of CI/CD practices and tools (e.g., GitHub Actions, CircleCI, Jenkins) Excellent verbal and written communication skills; able to work across time zones and functions Experience with Agile, Continuous Integration, TDD, Continuous Delivery, Pairing, Automated Testing Good prioritization, negotiation, and communication skills Experience with AWS, Azure, Google Cloud or Oracle Cloud Retail / Ecommerce experience is a must. Highest level of personal integrity, and the ability to professionally manage confidential matters and exude the appropriate level of judgment and maturity. Exceptionally self-motivated and directed. Must be able to support on and offshore teams. Dedication and commitment to top-quality service and to meeting customer expectations. Five Below is an Equal Opportunity Employer Explore our benefits site to discover all the perks and support we offer! From health coverage to financial and personal wellness, we've got you covered-check it out today! benefits.fivebelow.com/public/welcome Five Below is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity or any other factor protected by applicable federal, state, or local laws. Five Below is committed to working with and providing reasonable accommodations for individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please submit a request and let us know the nature of your request and your contact information. crewservices.zendesk.com/hc/en-us/requests/new BE AWARE OF FRAUD! Please be aware of potentially fraudulent job postings or suspicious recruiter activity by persons that are posing as a Five Below recruiters. Please confirm that the person you are working with has an @fivebelow.com email address. Additionally, Five Below does NOT request financial information or payments from candidates at any point during the hiring process. If you suspect fraudulent activity, please visit Five Below's Career Site to verify the posting. fivebelow.com/info/careers

Posted 30+ days ago

King's Hawaiian logo
King's HawaiianTorrance, CA
Joining King's Hawaiian makes you part of our ohana (family). We are a family-owned business for over seventy years, respecting our roots while thinking about our future as we continue to grow and care for our customers and the communities we serve. Our ohana members build an environment of inclusivity as they freely collaborate, pursue learning through curiosity, and explore innovation as critical thinkers. Beyond that, we are also passionate about supporting the long-term health and well-being of our employees and their families. If you're excited to rise with our team, come and join our `ohana! The Quality Assurance Technologist serves as senior QA technical resource and liaison between departments, who reports directly to the QA Supervisor and dotted line to the QA Manager. The critical technical functions of the position are to assist the QA Management to execute projects, develop, implement, maintain, provide training on and ensure effectiveness of site food safety and quality functions. The individual must have a quality conscious attitude with emphasis towards a teamwork approach to accomplish project goals and implement solutions to problems. The individual will work independently, be able to multitask, detail oriented, and have good decision-making skills based on the quality process from the beginning of manufacturing to the end. The individual will continually seek to improve oneself and provide technical information to other departments. PRINCIPAL ACCOUNTABILITIES Perform routine raw material and finished product QA/C functions as assigned by QA Management, which include but are not limited to the following: Process audit Laboratory QA/C testing and equipment calibration Product sensory evaluation Execute non-conformance product protocol (i.e., Hold) Assure compliance with food safety and quality standards throughout all operations and processes by conducting process/system audits, developing and implementing corrective actions. Assist SQF Practitioner to ensure SQF certification compliance by performing validation audit, updating and developing food safety protocols Collect, review, interprets, verify and analyze process QA/C data to identify process improvement opportunities. Participate in departmental and cross-functional continuous improvement projects as assigned by QA Manager. Assist QA Management to determine root causes for food safety and quality related issues, develop and implement corrective action plans. Assist QA Management to generate and to issue food safety and quality reports. Serve as senior technical resource for QA Technicians and other Operations personnel. Train new QA Technicians as required by QA Management. Perform other relevant duties assigned by QA Management. Actively participate to assure cross-functional issues are resolved and site concerns are addressed. Advises the QA and site Management of quality issues in a timely manner. Places on hold items that do not meet the specifications such as incoming material, work in process, and or finished goods. Presents reasons for retention and recommends possible solution to the issue. Inspects and calibrates equipment used in the lab. Report non-compliance findings and recommends next step solutions to QA and site Management on a timely manner. Monitors and enforces GLPs (Good Laboratory Practices), GMP (Good Manufacturing Practices) HACCP (Hazard Analysis Critical Control Points), and other employee safety, food safety and quality programs throughout the manufacturing facility. Informs, advises and updates company management of all quality related issues. Reviews, interprets, verifies, and summarizes data collected from other departments. Reports any deficiencies to QA Management in a timely manner. Responsible to generate relevant reports and conduct periodic internal site inspections. Assists QA Supervisor on various projects. Conducts SQF, GMP and other Food Safety and Quality trainings. Responsible for CCP verifications Responsible for Quality and Food Safety functions as assigned and outlined in Safe Quality Food (SQF) Program. Responsible for reporting all quality and food safety concerns/issues to QA. QUALIFICATIONS High school diploma or GED equivalent BS degree in Microbiology, Food Science, Biology or other related technical field. 2 - 3 years of QA/QC experience in food manufacturing or related fields Strong working knowledge of common food QA/C laboratory methods. Strong working knowledge HACCP and pre-requisite programs. Demonstrated working knowledge of current SQF Food Safety Program, BRC certification, or other GFSI certification requirements. Hands-on GMP / Food Safety / Quality System audit experience. Familiar with current food regulatory requirements and standards such as those of cGMP Demonstrates problem solving skills. Able to effectively communicate verbally as well as in writing; demonstrate ability to write effective technical procedures and reports; bilingual in English / Spanish is preferred. Able to take on projects with minimum supervision, complete tasks in a proficient manner, and work as a team Demonstrates ability to work effectively in team based and fast paced environment. Demonstrates effective project management and/or execution skills. Demonstrates intermediate to advanced computer skills: MS Excel / Word / Outlook. Able and willing to work flexible schedule. Desired Personal Traits Team player with good communication, collaboration, and interpersonal skills. Highly motivated, takes initiative, and able to lead and follow. Critical and independent thinker. Flexible, adaptable, and willing to handle an ever-changing work environment. Have a "can-do" attitude and be open to constructive feedback and coaching Committed to continuous improvement of self and team Strong organizational skills; results oriented; tenacious; creative. Note: This position description indicates the critical features of the role as they are presently envisioned. They are subject to change at any time due to business conditions or other reasons. The incumbent may be asked to perform other duties as required. Compensation Range: $ 25.25 - $37.25 King's Hawaiian is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for our ohana.

Posted 30+ days ago

KBI Biopharma logo

QA Manufacturing Specialist I/II

KBI BiopharmaDurham, North Carolina

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Job Description

Position Summary:

We are seeking a highly motivated QA Manufacturing Specialist I/II at our state-of-the-art commercial manufacturing facility in Patriot Park, Durham, NC. 

You will have the unique opportunity to help build our site processes and culture as we ramp up to full manufacturing capacity. We embrace KBI’s values of learning and growth, high standards, collaboration, and trust and respect to solve problems and continuously improve.  As a center of excellence, our site enables real-time quality and process monitoring through paperless records with integrated automation.  We are looking for a critical thinker who is comfortable tackling new challenges / unknowns and utilizing a risk-based approach.  We hope you join us!

Position Responsibilities:

  • Be an on-the-floor quality partner working with the manufacturing team during operations

  • Work with manufacturing and other groups to escalate and resolve deviations and other compliance issues

  • Conduct QA walkthroughs

  • Participate in safety walkthroughs

  • Participate in process improvements

  • Attend relevant meetings in support of manufacturing operations

  • Review electronic batch records and logbooks

  • Provide feedback on facility response for unplanned events

  • Other tasks and projects as assigned

  • Work 12-hour shifts (2-2-3 schedule, day shift)

Position Qualifications:

MQA Specialist I 

  • High School diploma or equivalent. 
  • Degree progression preferred. GMP / regulated industry / laboratory experience is required (approximate 1-3 years). 
  • Demonstrated ability to work in a team environment. 
  • Demonstrated ability to understand the manufacturing process. 
  • Ability to perform routine core MQA responsibilities. 

MQA Specialist II

  • Associate degree / bachelor’s degree strongly preferred or appropriate years of experience (approximate 3-5 years).
  • Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization. 
  • Demonstrated ability to represent Quality on interdepartmental meetings. 
  • Demonstrated knowledge of technical documents. 
  • Ability to support internal and external audits. 
  • Demonstrated ability to train employees on Quality subjects. 
  • Ability to track and trend department metrics

 

Salary Ranges:

MQA Specialist I: $54,000 - $74,300

MQA Specialist II: 66,966 - 92,077

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.  

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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