Senior Quality Assurance Validation Contractor

in Pharma Contract

Job Detail

  • Experience Level Senior
  • Degree Type Bachelor of Science (BS)
  • Employment Consulting
  • Working Type On Site
  • Job Reference 0000009122
  • Salary Type Hourly
  • Industry Pharmaceuticals
  • Selling Points

    Opportunity to work for biopharma company focused on developing rare disease treatments.

Job Description

Senior Quality Assurance Validation Contractor

1 year initial contract

Responsibilities

Provide onsite QAV support (Monday through Friday) in Woburn, MA to support the following QAV activities:

·       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 in Bedford, MA

·       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.

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