Job Information
Abeona Associate, Quality Control in Cleveland, Ohio
Position Overview
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.
Qualifications
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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