Position located in Waltham, MA

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.