Senior QAV Specialist

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