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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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The Senior Quality Assurance Validation Contractor is a full-time, on-site contract position at the GTMF Site in Bedford, MA. This contract position is for a lead QA Validation contract role supporting the GTMF Site.
Responsibilities:
Requirements / Qualifications:
Sr. QAV Specialist
Posted: 01/13/2026
2026-01-13
2026-02-24
Employment Type:
Contract
Job Category: Quality
Job Number: 4819
Job Description
The Senior Quality Assurance Validation Contractor is a full-time, on-site contract position at the GTMF Site in Bedford, MA. This contract position is for a lead QA Validation contract role supporting the GTMF Site.
Responsibilities:
- Provide onsite QAV support (Monday through Friday)
- Review and approval of analytical instrument qualification (AIQ) protocols, reports, validation issues, specifications, and assessments.
- Review and approval of periodic reviews for analytical instruments and lab system.
- 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 QAV support needs, provide supplemental onsite support at the Manufacturing Facility
- Provide a weekly burn rate on hours used and remaining on the PO.
Requirements / 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.
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Explore exciting job opportunities in and around Bedford, Massachusetts! Located in Middlesex County, just a short drive from Boston, this charming town offers a perfect blend of suburban tranquility and urban convenience. With close proximity to historic sites like the Bedford Flag and the Minute Man National Historical Park, as well as a thriving arts scene showcased at the Higgins Art Gallery, job seekers can enjoy a rich cultural experience while advancing their careers. Indulge in delicious New England cuisine, catch a show at the nearby Merrimack Repertory Theatre, or cheer on the beloved Boston Red Sox at Fenway Park. Embrace the picturesque beauty of nature at nearby Bedford Center Park or take a stroll by the Concord River. Don't miss the chance to grow both personally and professionally in this vibrant and dynamic region!