Our client, a leading Life Sciences company, is hiring a Sr. QAV Specialist.

Work Location: Middlesex County, Massachusetts

Summary:

The Senior Quality Assurance Validation Contractor is a full time on site contract position. This contract position is for a lead QA Validation contract role supporting the site.

Responsibilities:

• Provide onsite QAV support (Monday through Friday) to support the following QAV activities:
• Review and approval of analytical instrument qualification (AIQ) protocols, reports, validation issues, specifications, and assessments.
• Review and approval of periodic reviews for manufacturing.
• Review and approval of data integrity assessments and audit trail reviews for manufacturing.
• Review and approval of BMRAM work orders for manufacturing.
• Review and approval of equipment, facility, and utility system validation lifecycle documents (e.g., SLRA (System Level Risk Assessments), DI (Data Integrity) Assessments, DR/DQ, Specifications, IQ/OQ/PQ Qualification Protocols/Issues/Reports, Risk assessments (potential to facilitate risk assessments)).
• Independently represent QAV in cross functional project meetings.
• Communicate and make quality decisions supporting elements of the qualification/ validation lifecycle during cross functional project team meetings based on guidance in program SOPs, Quality Standards, and industry regulations.
• Based on QAV support needs, provide supplemental onsite support at the Manufacturing Facility.
• Provide a weekly burn rate on hours used and remaining on the PO.

Qualifications:

• Minimum B.S. degree in Engineering or other Science field such as microbiology, chemistry or biochemistry.
• Experience in biopharmaceutical or biotechnology based GMP operations with experience in Quality and/or Validation roles.
• Direct experience with analytical instrument qualifications, computer system validation/computer software assurance, and data integrity programs.
• Knowledge of relevant FDA and EMA regulations.
• Ability and willingness to work in a fast-paced environment that will require a combination of individual contribution and team leadership.
• Direct experience reviewing and/or authoring CMC sections of regulatory filings.
• Excellent oral and written communication skills with strong technical writing experience required.
• Excellent organizational skills and attention to detail.
• Demonstrated analytical approach to problem solving and decision making.
• Demonstrated ability to manage multiple priorities for complex projects.
• Experience with continuous improvement efforts.

Published Category: Quality & Validation