Responsibilities of the Quality Assurance Specialist:
May be required to assist with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs.
Provide QA support of change controls, GMP investigations and CAPAs.
Participate in compliance walkthroughs and help drive the closure of any audit observations.
Generation, review and maintenance of Quality System documentation and procedures.
Provision of suggestions and comments, evaluation and approval of changes directly related to the critical systems, manufacture and analytical methods.
Review of standard operating procedures.
Review of GMP related documents, such as specifications, methods, validation documents, technology transfer documents, etc.
Requirements of the Quality Assurance Specialist:
BS degree in Biology, Chemistry, or related area.
Must have 3+ years Quality Assurance in a GMP environment.
Experience providing QA support and oversight of GMP manufacturing operation including equipment/ facilities qualification, utilities and batch release.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance, Science, and Research
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Commonwealth Sciences, Inc. by 2x