A recognized company in the Bedford, MA area is seeking a new Senior QAV Specialist for a one-year onsite contract. In this role, the Senior QAV Specialist will be responsible for providing full-time quality assurance validation support and participating in cross-functional project meetings.
About the Opportunity:
- Schedule: Monday to Friday
- Hours: Standard business
Responsibilities:
- Reviewing and approving analytical instrument qualification protocols, reports, and validation issues
- Review and approval of periodic reviews for manufacturing
- Review and approval of data integrity assessments and audit trail reviews
- Review and approval of equipment, facility, and utility system validation documents
- Independently representing QAV in cross-functional project meetings
Qualifications:
- Minimum B.S. degree in Engineering, Microbiology, Chemistry, or Biochemistry
- Experience in Biopharmaceutical or Biotechnology-based GMP operations
- Direct experience with analytical instrument qualifications and data integrity programs
- Knowledge of relevant FDA and FMA regulations
Desired Skills:
- Experience in Continuous Improvement efforts
- Experience authoring CMC sections of Regulatory filings
- Experience with Computer System Validation / Software Assurance
- Strong experience in Technical Writing
