- Kedplasma (Cinnaminson, NJ)
- …overseeing all activities related to product quality , and ensuring product quality . . Ensures production personnel follow compliance of all Center activities ... relevant experience, education and certifications. **JOB SUMMARY** Manages plasma collection centers' Quality staff and ensures quality standards are met with… more
- Actalent (Princeton, NJ)
- … data and metrics to identify trends and areas for improvement. + Ensure compliance with FDA , EMA, and other applicable regulatory standards for cell therapy ... Job Title: Quality Assurance AssociateJob Description We are seeking a...CFR Parts 210, 211, 1271), and relevant ICH and FDA guidance. + Demonstrated ability to lead and close… more
- J&J Family of Companies (Raritan, NJ)
- …serves as the clinical supplier quality point of contact to ensure quality of the GxP system, compliance with regulatory requirements and SOPs, and ... expert and liaison for Clinical Business Units and R&D functions, ensuring quality and regulatory compliance within the organization. **Key Responsibilities:** +… more
- Edgewell Personal Care (Allendale, NJ)
- …This role combines strong analytical capabilities with a deep understanding of compliance , quality metrics, and regulatory requirements. The analyst will lead ... + Collaborate with cross-functional teams to enhance visibility of compliance and quality performance across global sites...Operations Analytics + Exposure to regulatory standards such as FDA , EU MDR, ISO 13485 or GMP preferred +… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …for establishing standards and implementing procedures to ensure that the business units quality management and compliance program are effective and efficient in ... compliance and mitigating risks, The performance of the Quality Systems and Risks will be reported periodically to...Bachelor's degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment +… more
- Catalent Pharma Solutions (Princeton, NJ)
- …help the team with Raw material work by being responsible for ensuring the quality and compliance of raw materials used in pharmaceutical manufacturing. This ... committed to a Patient First culture through excellence in quality and compliance , and to the safety...support method development/validation, and ensure audit readiness. + Maintain compliance with SOPs and regulatory requirements ( FDA ,… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …+ Coordinate, prepare, and complete premarket applications to the US FDA , including Premarket Notification [510(k)], Pre-Sub, and De Novo submissions in ... a timely manner. Act as liaison with FDA regarding product submissions. Experience in Safer Technologies Program (STeP), Breakthrough Device designation, and… more
- Kelly Services (Somerset, NJ)
- …maintain, and troubleshoot quality software tools to ensure optimal performance and compliance . + Collaborate with IT and Quality teams to implement system ... ** Quality Validations Engineer- Somerset NJ** **Summary of Essential...(eg, MasterControl), LIMS, and ERP systems. + Familiarity with FDA 21 CFR Part 11 compliance and… more
- Integra LifeSciences (Plainsboro, NJ)
- …of care. **SUMMARY DESCRIPTION** The ** Quality Assurance Engineer II** will provide Quality compliance support on all aspects of the Plainsboro, NJ CMC ... Quality System. The Quality Assurance Engineer II...development, manufacture and distribution of medical products is in compliance with corporate policies, US Food and Drug Administration… more
- Promotion In Motion (Somerset, NJ)
- Quality Control Technician Job Details Job Location Somerset - Somerset, NJ Position Type Full Time Salary Range $19.00 - $21.00 Hourly Job Category QA - Quality ... and finished products. Reject products in non-conformance. Report food safety and quality problems to Plant Management and SQFP to initiate action. Instructions… more