Associate, Quality Control
3 weeks ago
The Quality Control Associate performs routine laboratory activities in support of GMP testing for Quality Control. Testing includes raw material, packaging components, in-process and finished product. Interacts with employees internal and external to Quality Control.Essential Duties and Responsibilities
- Works on QC tasks of diverse scope, requiring basic knowledge of laboratory concepts.
- Performs sampling and laboratory testing of raw materials, in-process samples and finished drug product analysis, using standard techniques in biochemistry, molecular biology and cell biology, and according to approved test methods.
- Completes laboratory work with precision, and maintains hardcopy paperwork and electronic data in organized manner, in compliance with company documentation practices (GDP).
- Participates validation/qualification of methods transferred into the QC laboratory.
- Provides input to improving QC systems and procedures to improve Good Manufacturing Practice compliance.
- Reviews and revises analytical methods, SOPs, test records, and critical reagent specifications.
- Proactively communicates laboratory issued to manager.Supports laboratory investigations related to test failures, discrepancies and deviations.
- Helps maint laboratory in GMP compliant state, including participating in cleaning, instrument routine and preventative maintenance, logbook use, etc.
- Performs other duties as assigned by management.
- BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with 1 to 4 years of relevant experience.
- Experience and knowledge in the pharmaceutical and/or biotech industry within a GMP and/or GLP environments preferred.
- Experience in Immunostaining, ELISA, PCR, biochemical assays, cell culture and cell based potency assays preferred.
- Understanding of basic scientific concepts in one or more areas above.
- Experience with relevant analytical lab equipment and computers preferred.
- Good mathematical and organizational skills
- Ability to interact constructively with co-workers to solve problems and complete tasks
- Some weekend work or late nights may be required periodically.
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