As a Quality Assurance Specialist you will be responsible for documenting and auditing cGMP practices for the site. The position develops and revises QA procedures to strengthen cGMP compliance as per the USFDA Title 21 Code of Federal Regulation Part 210, 211 and Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Key Responsibilities:
Required Skills/Abilities: BS/BA in science with 1-3 years Quality Assurance cGMP experience or an Associate degree with 5+ years of Quality Assurance cGMP experience in the area of Active Pharmaceutical Ingredients (API) manufacturing or related industrial experience. High level of knowledge in cGMP guidelines as specified in ICH Q7A. Experienced at writing and reviewing GMP documents. Solves complex, non-routine analytical problems. Very strong oral and written communication skills.
The annualized salary range for this position is between $58,100.00 - $71,100.00.
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