Location: On-site in Woburn, MA
Length: 8 months (through end of 2025)
Summary: The Senior Quality Assurance Validation Contractor is a full-time, on-site contract position at the client's QC Laboratories in Woburn, MA. This contract position is for a QA Validation role supporting analytical instrument qualifications, computer system validation, and data integrity projects.
Duties/Responsibilities:- Review and approval of analytical instrument qualification (AIQ) and computer system protocols, reports, validation issues, specifications, and assessments.
- Review and approval of periodic reviews for analytical instruments and lab systems.
- Review and approval of data integrity assessments and audit trail reviews for lab systems.
- Review and approval of BMRAM work orders for lab systems.
- 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 client's QAV support needs, provide supplemental onsite support at the Manufacturing Facility in Bedford, MA
Qualifications/Requirements:- 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.
- 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.