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Engineer Senior, Physical Test Methods, Drug Delivery Device

3 Key Consulting  –  Thousand Oaks, CA, 91320
... characterization, scale-up, technology transfer experience, pFMEAs and dFMEAs Experience with change controls, deviations, CAPA Experience with combination products and device regulatory requirements Understanding of the six sigma process, utilizing ... - Dec 28

Supply Chain Quality Manager

NeoImmuneTech, Inc.  –  Rockville, MD, 20850
... distribution-related events such as complaints, deviations, returns, and temperature excursions, including escalation and CAPA as required Maintain inspection readiness and act as the point of contact for internal/external audits and regulatory ... - Dec 20

Senior Engineering Manager - Pharmaceutical Aseptic Filling

Management Recruiters of Edison  –  Spokane, WA
... Own equipment related deviation and CAPA investigation and remediation. Team Management:Supervise and mentor a team of 10 technical engineers. Foster a culture of safety, quality, and continuous improvement. Vendor Management: Quality, select and ... - Dec 30

Engineer Principal, Automation

3 Key Consulting  –  Thousand Oaks, CA, 91320
... Own and close deviations/CAPA within agreed upon timelines. Day-to-day Operational Support including: \ Participate in the 24 x 7 Onsite/On Call rotation. Troubleshooting Support to Mfg. Operations Automation System Administration Automation System ... - Dec 28

Associate Engineer, Biotech Lab/Equipment Testing - Hybrid

3 Key Consulting  –  Thousand Oaks, CA, 91320
... Research and Development, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory) on protocol review, testing preparation, change control process, deviation & CAPA, and controlled documentation Ensure cGMP and regulatory compliance are met ... - Dec 28

Qualification Specialist

Biospectra Inc  –  Bangor, PA
... Work closely with multiple divisions to coordinate qualification efforts and resolve any potential issues through BioSpectra’s change control program or CAPA program Review and approve external manufacturer qualification documentation to ensure it ... - Dec 30

Director of Quality (Systems/Semi conductor)

Auradine  –  Santa Clara, CA, 95051
... * Own failure analysis (FA), root-cause investigations, and corrective / preventive actions (CAPA) for internal, supplier, and customer issues. * Lead supplier quality engineering: supplier selection, audits, PPAP, process capability, and ongoing ... - Dec 22

Quality Engineer 2, Device Quality Operations

GRAIL  –  Durham, NC
... Support qualifications & validation activities (IQ/OQ/PQ/TMV) Support DHR review process Support NCR, DAR & CAPA process Support change management workflows, and acceptance activities including incoming and finished product release. Support Quality ... - Dec 30

Sr. Quality Records Investigator

Harvest Technical Services, Inc.  –  Houston, TX
... Routine interaction with the customer, including compilation of Power Points to communicate investigational current status, Alignment meetings, facilitated reviews, CAPA discussions, Comments resolution. Work on the manufacturing floor for data ... - Dec 20

Senior Specialist, Quality Systems Technology (QST)

Corcept Therapeutics  –  Redwood City, CA, 94063
... In this role, you'll manage security settings, while ensuring compliance and operational efficiency for key quality processes like deviations, change control, CAPA, and document management. You will also handle business administration tasks, ... - Dec 19
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