CONTRACT: 8-9 month contract to start MUST HAVES:- Minimum B.S. degree in Engineering or other Science field such as microbiology, chemistry or biochemistry.
- 5+ years 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.
Summary The Senior Quality Assurance Validation Associate is a full time on site contract position at the QC Laboratories in Woburn, MA. This contract position is for a QA Validation contract role supporting analytical instrument qualifications, computer system validation, and data integrity projects at the QC Laboratories.
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 QAV support needs, provide supplemental onsite support at the Manufacturing Facility at 170 Middlesex Turnpike in Bedford, MA
- Provide a weekly burn rate on hours used and remaining on the PO.
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.