What are the responsibilities and job description for the MQC Supervisor position at Sci.bio Recruiting?
Responsibilities
- Monitors daily workloads and manufacturing schedules to establish testing priorities, plans daily activities, and coordinates with MQC team.
- Interfaces with other departments to coordinate testing, environmental monitoring, equipment maintenance, calibration, and requalification.
- Communicates and coordinates testing activities with clients, vendors, and contract testing laboratories.
- Reviews and approves test results ensuring laboratory tests are accurately performed by trained and qualified scientists in a safe and compliant manner.
- Investigates and documents laboratory invalid, out-of-specification, and out-of-expectation results according to procedures and cGMP.
- Authors and manages deviations including associated investigations and actions.
- Authors and implements CAPAs including associated effectiveness checks.
- Drafts and reviews procedures, specifications, forms, and other documents as needed to support cGMP.
- Ensures that laboratory documents and data (paper and electronic) are properly classified, controlled, and stored per Selkirk’s procedures.
- Bachelor’s degree in Microbiology, Biology, Chemistry or other related scientific discipline or a combination of bachelor’s degree and pertinent, progressive experience in pharmaceutical industry.
- Five (5) years’ experience in Microbiological Quality Control activities including instrumental analysis, wet chemistry analysis.
- Two (2) years’ GMP experience or regulated industry.
- Supervisory and/or leadership experience preferred.
- Knowledge and experience in 21 CFR Part 210 and Part 211, and Part 11. Knowledge of FDA cGMP, GAMP 5, Eudralex Volume 4 Annex 1, USP, EP, and other industry related guidance documents.
- Mastery of microbiological test methods and best practices. High familiarity with isolate identification, bioburden testing, endotoxin analysis, sterility testing in isolator, and other microbiological assays required for sterile injectable drug product testing.
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