Maintain quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines. Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. Typical duties include:
•Review executed production documentation for completeness
•Draft and revise master production documentation, including batch records and work instructions to ensure GMP compliance and meet project milestones
•Draft, review and complete change control documentation including deviation reports, non-standard reports and standard operating procedures
•Draft and revise validation documentation
•Draft and revise stability study documentation
•Create and maintain project files organizing production documentation
•Maintain equipment qualification files
•Assist with sampling and release of manufactured material
•Assist with ordering, receiving, sampling and release of raw materials
•Assist with internal, regulatory and customer audits
•Provide solutions to a variety of moderately complex technical issues



Requirements:

•Bachelor degree required, preferably in Scientific field
•Three years experience working in a GMP environment
•Three years experience in Quality Assurance/Quality Control
•Previous experience working in a pharmaceutical environment
•Additional experience in validation and corrective / preventative actions (CAPA) desired
•Excellent verbal and written communication skills
•Good working knowledge of MS Word, MS Excel
•Utilize time management skills and techniques
•Ability to work independently in a team environment

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