Union City, CA
... Manufacturing processes, Quality System Programs – 8D, CAPA, NCR, Audit. Familiarity with OSHA, FDA, GMP standards. EDUCATION: Mechanical Engineering Technology Two years Southern Utah University Cedar City, Utah Three years Diploma in Mechanical ...
- 2023 Nov 27
Fremont, CA
... Review investigations, deviation, and CAPA. SME for analytical guidance and product shelf life for product development, regulatory, QA, and legal. Write justification, CMC, annual product review, and other scientific document to support QA and QC ...
- 2023 Nov 17
Riverside, CA
... Responsible for ASL, CAPA, QKPIs, CofCs, FAIR (AS9102 form1-3), and required documentation for complete lot control and traceability of material/process and verification meeting or exceeding customer base requirements. Effective implementation of ...
- 2023 Nov 17
Alpine, CA
... FDA 21 CFR Part 820 Program, CDMO’s, NCMR’s Program, CAPA Program, SCAR Program, OEE Program, FMEA Program. TPS, 6 “S’s”, 8 Mudas, Gemba walks to find Kaizen events specially for EHR, VSM, Validations: IQ, OQ, PQ Program. Root cause analysis, Cause ...
- 2023 Nov 12
San Francisco, CA
... Led non-conformance investigation thoroughness with appropriate and timely CAPA implementation by interfacing with regulatory bodies. Additional Experience Utilities Supervisor, Bristol Myers Squibb, Manati, PR Utilities Leader, Bristol Myers Squibb ...
- 2023 Nov 12
La Habra, CA
... Knowledge of Federal and State Laws and Regulations related to a medical device industry, including ISO production standards, GMP, cGMP, Lean Six Sigma, Corrective Action and Preventative Action Processes (CAPA) and the fundamentals of Total Quality ...
- 2023 Nov 10
Stockton, CA
... • Analyzing the customer complaints and circulating the reports for the Corrective Action Preventative Action (CAPA) along with maintaining the databases for CAPA and Supplier CAR. EDUCATION PhD in chemical Engineering- Biotechnology PhD thesis: ...
- 2023 Nov 09
Irvine, CA
... Systems Expert with years of experience and broad background in Quality Assurance (QA), Quality Systems (QS), Complaint Management, Post Market Surveillance, Supplier Quality Management, Internal and External Audits, SCARs and CAPA management; ...
- 2023 Nov 04
Calabasas, CA
... Northridge, CA February 2023–October 2023 Staff Quality Engineer Utilized cGMP principles, concepts, practices, and standards, participated in a CAPA activities for remediation of instruments and equipment with Full/Limited Calibration and No ...
- 2023 Nov 01
Van Nuys, CA
... Troubleshooting: Cables and harnesses on PCB assemblies Generation: ECN’s & ECO’s - Corrective actions and Preventive Actions (CAPA) documentation. Data Entry: Entering into database(s) and distributing reports as required. Re-work: P.C. Board ...
- 2023 Oct 31