Sr. QAV Specialist (Biotech/Pharma)

JOB DESCRIPTION

Position Summary

The Senior Quality Assurance Validation Contractor is a full time on site contract position at the QC Laboratories in Woburn, MA. This contract position is for a lead QA Validation contract role supporting the QC Laboratories.

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.

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.