Overview
Senior QA Validation Contractor Jobs in Woburn, MA at The Steely Group
Title: Senior QA Validation Contractor
Company: The Steely Group
Location: Woburn, MA
The Senior Quality Assurance Validation Contractor is a full time onsite contract position at the QC Laboratories in Woburn, MA. This contract position is for a QA Validation contract role supporting analytical instrument qualifications, computer system validation, and data integrity projects.
Responsibilities:
Review and approval of analytical instrument qualification (AIQ) and computer system protocols, reports, validation issues, specifications, and assessments.
Review and approval of periodic reviews for analytical instruments and lab systems.
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 the company’s QAV support needs, provide supplemental onsite support at the Manufacturing Facility.
Provide a weekly burn rate on hours used and remaining on the PO.
Requirements:
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.
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.
