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North Brunswick, NJ, 08902
... Experienced in Corrective and Preventative Action (CAPA) in analytical roles. Knowledge of 21 Code of Federal Regulation parts 11, 50, 54, 56, 312, 314 Capable of Serious Adverse Event (SAE) reporting and Individual Case Safety Reporting (ICSR). ...
- 2023 Dec 22
Edison, NJ
... • Highly experienced in CMMS maintenance systems (Infor and Blue Mountain) and Trackwise quality systems for change control, CAPA’s and deviation investigations. • Install, troubleshoot, and maintain GMP validated equipment for production lines and ...
- 2023 Dec 20
Princeton, NJ, 08540
... manufacturing organization (CMOs) and contract packaging organization (CPOs) Review/approval of Change control, Deviation, CAPA associated with batches Review Certificate of Analysis to ensure that all established testing criteria are met for ...
- 2023 Dec 14
Parsippany, NJ
... Key Strengths Strategic Operations Leader Manpower, Manufacturing & Production Planning Quality Assurance, RGA & Scrap Reduction, Capa’s Product Coordination and Development Customer Service Inventory Management Work History Euroimmun – Lead ...
- 2023 Nov 17
Hillsborough, NJ
... and periodic reviews on the system e-workbook, HP Application Lifecycle Management (ALM) • Participated in Incident Management of computerized systems and investigated the root cause of the incidents, GxP impact, and required CAPA activities. ...
- 2023 Nov 17
Somerset, NJ
... Highly effective at contributing to drug development and technology transfer, facilitating GMP audits, CAPA, and root cause analysis, and clearly and concisely liaising with agencies and clients. Encouraging mentor, excellent team leader and ...
- 2023 Nov 16
Monmouth Junction, NJ
... • Proficient knowledge of quality systems including CAPA, change control, and document management systems like VeevaVault. • Championed good documentation practices and unwavering commitment to regulatory requirements, ensuring full compliance with ...
- 2023 Nov 10
New Brunswick, NJ, 08989
... (i.e Deviation, CAPA, Protocol, Report, PMR, SOPs etc.) Coordinate with QA and warehouse personnel to ensure availability of required materials. Motivate a diverse workforce of all employees to exceed department goals, which includes safety, quality ...
- 2023 Oct 30
Piscataway, NJ, 08854
... and issue material status notifications Facilitated and participated in deviations, corrective action and preventive action (CAPA) activities, and complaints for assigned projects Served as QA lead on project teams, in complex quality investigations ...
- 2023 Oct 25
Green Knoll, NJ, 08807
... Dena Bayoumi, PharmD CAPA: address & prevent customer & patient complaints; results oriented interaction and effective communication skills with Quality Control team members, project leaders, Sample Management, & Quality Assurance departments to ...
- 2023 Jul 21