Sr. QA Specialist

Sr. QA Specialist

This is a Flex role that will typically require onsite work 3-4 days each week, or more depending on business needs.

1 year initial contract

JOB DESCRIPTION

The Senior QA Specialist will collaborate closely with the internal QC laboratories and other departments within the client's network.

Responsibilities

·       Provide active support for QC site operations, inclusive of associated facilities, lab operations and IT operations.

·       Partner with QC and support teams relative to quality/compliance aspects of changes and systems.

·       Provide review and approval of analytical method validation protocols, reports, and data packages.

·       Generate and approve Certificates of Analysis (COAs) in LIMS to support batch release and regulatory filings.

·       Provide Analytical QA approval of deviations and change controls.

·       Support site/departmental inspection readiness programs, as needed.

·       Provide quality system guidance and support for the QC laboratories, including data review processes, to ensure the health of the quality systems.

·       Utilize risk management principles to continuously improve QC related processes and procedures.

Requirements

·       Minimum B.S. degree in preferably microbiology, chemistry or biochemistry.

·       7 years of Quality Assurance experience in biopharmaceutical or biotechnology based GMP setting with a focus on Quality Control. 

·       Experience with both internal QC operations and external contract test lab operations is preferred.

·       Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections. 

·       Experience leading continuous improvement efforts.