A recognized pharma company in Massachusetts is actively seeking a new Senior QAV Specialist for a one-year contract near Bedford, MA.
About the Opportunity:
- Schedule: Monday to Friday
- Hours: Standard business
- Setting: Onsite
Responsibilities:
- 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
- Provide supplemental onsite support at the Manufacturing Facility
- Provide a weekly burn rate on hours used and remaining on the PO
Qualifications:
- Bachelor's Degree in Engineering and/or Science-related field (Biochemistry, Chemistry, and/or Microbiology)
- Experience in Biopharmaceutical or Biotechnology-based GMP operations
- 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 FMA regulations
- Experience with Continuous Improvement efforts
- Direct experience reviewing and/ or authoring CMC sections of regulatory filings
- Demonstrated analytical approach to problem-solving and decision-making
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