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QC Associate, Bioanalytical

Company: Apex Systems
Location: Ventura
Posted on: November 22, 2020

Job Description:

Seeking a Bioanalytical QC Associate This Quality Control Associate (Cell Culture) role primarily performs routine operations in a Biological Safety Cabinet using strict sterile technique while maintaining compliance with cGMP regulations including Good Documentation Practices (GDP). Primary Responsibilities Supports the cGMP compliant QC bioanalytical laboratory, as needed. Support QMS systems deviations, investigations, root cause analyses and solution implementation. Supports QC- Analytical management during internal and external inspections and audits. Education and Professional Experience Requires minimum Bachelor of Science Degree in Molecular and Cellular Biology, Immunology, Biochemistry, Biology, or other Biotechnology disciplines 0 - 5 years of experience. Quality control experience in the pharmaceutical industry supporting cGMP areas desired. Experience in cGMP cell therapy manufacturing andor testing facility is a plus. Position Requirements Must be able to work in controlled environments requiring special gowning for biosafety. Excellent verbal and written communication skills, good interpersonal skills and a high attention to detail required. Must enjoy working in a fast paced, highly dynamic environment Knowledge of relevant regulations and FDA guidance is desired. Expected to rigorously follow Standard Operating Procedures (SOPs), Work Instructions (WINs), and Analytical Methods (MTDs) needed for a cGMP compliant Quality Control bioanalytical laboratory Flexibility to work weekends, after hours, andor overtime as required to accommodate the business needs. Physical Requirements Subject to extended periods of sitting andor standing in a laboratory environment. Ability to lift 50 lbs. and to work in Blaboratory required. For consideration please email most up-to-date resume with contact information to Brittany Waldron LI-BW4

Keywords: Apex Systems, Ventura , QC Associate, Bioanalytical, Other , Ventura, California

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