Senior Quality Assurance Professional
6 days ago
KBI BioPharma is a leading biopharmaceutical company that strives to deliver high-quality products and services.
Job DescriptionWe are seeking an experienced Deviation Specialist to join our team. The successful candidate will be responsible for ensuring the timely review and approval of Deviations, CAPAs and ECs, in accordance with cGMP requirements and company SOPs.
Key Responsibilities- Collaborate with cross-functional teams to ensure completion of Root Cause Analysis, CAPAs and Effectiveness Checks (ECs) for Deviations.
- Review and approve Deviations, CAPAs and ECs, ensuring compliance with cGMP regulations and company policies.
- Provide training and certification to QA staff on Deviation/CAPA review and approval procedures.
- Support the development of training materials and training personnel to improve the Deviation/CAPA system.
- Attend relevant operational and project meetings to ensure effective communication and collaboration.
- Minimum BS in a scientific field with 14+ years' experience or MS and 11+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
- Experience with Quality Systems, including Batch Record review, supporting investigations and CAPAs.
- Knowledge of US, EU and ROW cGMP guidelines required.
The estimated salary for this position is $90,000 - $110,000 per year, based on current industry standards and market conditions.
BenefitsWe offer a comprehensive benefits package, including medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days, and employee recognition programs.
-
Senior Quality Assurance Specialist
5 days ago
Durham, North Carolina, United States Integrated Resources, Inc Full timeIntegrated Resources, Inc. is seeking an experienced Senior Quality Assurance Specialist to join our team in Durham, NC.About the RoleThis position will be responsible for environmental monitoring in aseptic environments, collection and processing of water samples, component, and product release testing. The ideal candidate must have strong interpersonal,...
-
Senior Quality Assurance Manager
6 days ago
Durham, North Carolina, United States U.S. Engineering Full timeWe are seeking an experienced Senior Quality Assurance Manager to join our team at U.S. Engineering.Job SummaryThis is a challenging opportunity for a seasoned professional with a strong background in quality assurance and control to lead our quality management initiatives.About the RoleThe successful candidate will be responsible for planning, directing,...
-
Senior Care Professional
5 days ago
Durham, North Carolina, United States Phoenix Senior Living Full timeAbout UsPhoenix Senior Living is a leading provider of senior care services, dedicated to delivering exceptional support and assistance to our residents.Job SummaryWe are seeking a highly skilled Med Tech / Certified Medication Aide to join our team. As a Med Tech, you will play a vital role in monitoring the health and well-being of our residents, providing...
-
Senior Quality Assurance Specialist
1 week ago
Durham, North Carolina, United States Lilly Full timeWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Lilly in Raleigh-Durham, North Carolina. As a member of our Quality Assurance department, you will play a critical role in ensuring the quality and safety of our parenteral and device products.About the RoleThe Senior Quality Assurance Specialist will be responsible for...
-
Senior Quality Assurance Specialist
7 days ago
Durham, North Carolina, United States Cambrex High Point Full timeJob SummaryCambrex High Point is seeking a highly skilled Quality Assurance Specialist II to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our products and services.Key Responsibilities:Perform independent quality evaluations and releases of support documentation, materials, products,...
-
Quality Assurance Manager
7 days ago
Durham, North Carolina, United States SBM Management Services Full timeJob OverviewSBM Management Services, LP is a leading provider of management solutions. We are seeking a highly skilled Quality Assurance Manager to join our team.
-
Quality Assurance Specialist
7 days ago
Durham, North Carolina, United States PEAK Technical Staffing USA Full timeJob DescriptionAt PEAK Technical Staffing USA, we are seeking a highly skilled Quality Assurance Specialist to join our team. This is a full-time position with a competitive salary of $16-$17/hour.The ideal candidate will have a strong attention to detail and be able to read instructions to understand quality expectations for products and raw materials.**Key...
-
Senior Software Quality Assurance Specialist
7 days ago
Durham, North Carolina, United States NetApp Full timeWe are seeking a skilled Software Quality Assurance Engineer to join our team at NetApp.Company OverviewNetApp is a leader in data management solutions, helping customers turn challenges into business opportunities. Our innovative approach combines fresh thinking with proven expertise to deliver exceptional results.Job SummaryThis role involves working...
-
Durham, North Carolina, United States Piper Companies Full timeJob OpportunityPiper Companies is a leading pharmaceutical company based in Durham, North Carolina.We are currently seeking a Biopharmaceutical Quality Assurance Specialist to join our team. The ideal candidate will be responsible for conducting quality walk-throughs of production, testing and warehouse locations, collecting samples for carbon, surface and...
-
Durham, North Carolina, United States Piper Companies Full timePiper Companies is a leading pharmaceutical company based in Durham, North Carolina. We are currently seeking a Biopharmaceutical Quality Assurance Specialist to join our team.
-
Quality Assurance Inspector
5 days ago
Durham, North Carolina, United States Corning Incorporated Full timeJob Description:At Corning Incorporated, we're shaping the industries that shape our world. As a Quality Assurance Inspector, you'll play a vital role in ensuring the quality of our products meets the highest standards.About the Role:Perform in-process and final inspections of products to ensure compliance with specifications.Accept or reject products based...
-
Quality Assurance Specialist
7 days ago
Durham, North Carolina, United States PEAK Technical Staffing USA Full timeJob Description:We are seeking a Quality Assurance Specialist to join our team at PEAK Technical Staffing USA in Durham, NC.About the Job:This is a full-time position that offers a competitive salary of $16-$17 per hour.Key Responsibilities:Ensure quality standards are met by reading instructions and approving or rejecting raw materials.Select material...
-
Durham, North Carolina, United States Insight Global Full timeSeeking an Environmental Monitoring and Quality Assurance Specialist to join Insight Global. This role is perfect for individuals who are passionate about environmental monitoring and quality assurance.About the Role:We are looking for a highly skilled and detail-oriented individual to perform sampling of air for viable and non-viable particle counts along...
-
Production Quality Assurance Specialist
3 days ago
Durham, North Carolina, United States TalentBurst Full timeWe are seeking a highly detail-oriented Production Quality Assurance Specialist to join our team at TalentBurst in Durham, NC. As a key member of our production team, you will be responsible for ensuring the quality and integrity of our products from start to finish.About the RoleThe ideal candidate will have at least 1 year of experience within a...
-
Quality Assurance Manager
4 weeks ago
Durham, North Carolina, United States SpringWorks Therapeutics Full timeAt SpringWorks Therapeutics, we are seeking a highly motivated individual to fill the role of Quality Assurance Manager. This position will play a crucial part in ensuring the reliability and compliance of our products in clinical, compassionate use, and commercial distribution channels.Key Responsibilities:Collaborate with internal stakeholders and external...
-
Senior Quality Supervisor
6 days ago
Durham, North Carolina, United States AISIN North Carolina Corporation Full timeJob Title: Senior Quality SupervisorAbout the RoleWe are seeking a highly experienced and skilled Senior Quality Supervisor to lead our Gauge Lab team at AISIN North Carolina Corporation. As a key member of our management team, you will be responsible for ensuring that our quality standards are met, and our processes are efficient and...
-
Durham, North Carolina, United States Fidelity TalentSource LLC Full timeJob SummaryWe are seeking a highly skilled Senior Data Engineer and QA Automation Specialist to join our Workplace Investing Quality Engineering team at Fidelity TalentSource LLC.About the RoleThis exciting new role within the Workplace Investing (WI) Data Engineering space requires a senior-level professional with expertise in designing, developing, and...
-
Senior Clinical Program Manager
7 days ago
Durham, North Carolina, United States Seasons At Southpoint Full timeSeasons at Southpoint: A Leader in Elder CareWe are seeking an experienced Senior Clinical Program Manager to join our team as a key member of our healthcare leadership team. As a Senior Clinical Program Manager, you will be responsible for overseeing the overall health and well-being of our residents, ensuring that they receive the highest quality care...
-
Medical Director
7 days ago
Durham, North Carolina, United States CenterWell Senior Primary Care Full timeAt CenterWell Senior Primary Care, we are dedicated to delivering exceptional senior-focused primary care services. As a Medical Director - Senior Care Specialist, you will play a vital role in shaping our care model and ensuring that our patients receive the highest quality of care.Company OverviewWe are a leading provider of proactive, preventive care to...
-
Senior Molecular Diagnostics Specialist
7 days ago
Durham, North Carolina, United States Cypress HCM Full timeJob Title:Senior Molecular Diagnostics SpecialistAbout Cypress HCMCypress HCM is a leading healthcare organization dedicated to delivering exceptional patient care and innovative medical services.Salary InformationWe offer an attractive salary range of $180,000 - $220,000 per annum, commensurate with experience.Job DescriptionMolecular Pathologist Role...