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Sr. Quality Assurance Validation Specialist

Sr. Quality Assurance Validation Specialist

Greater Boston Area

12 Month Contract

My client is a biotech company focused on Gene Therapy looking to add a Sr Specialist to their team to assist with Quality Assurance Validation related activities. The Quality Assurance Validation position is focused around QA support of validation and qualification programs. Primarily being responsible for the Quality review and approval of internal protocols and reports related to different types of Validation processes. These including but not limited to Cleaning, Commissioning, Computer System and Instrument Qualification Validation.

Primary Roles and Responsibilities

  • Provide QA support for internal QC testing laboratory and internal/external manufacturing
  • Provide support for validation including:
    • AIQ (Analytical Instrument Qualification
    • Computer System Validation (CSV)
    • Commissioning and qualification
  • Review and Approve internal validation protocols and Validation Master Plans from a Quality prospective
  • Display the ability to make final QA decisions
  • Ability to multitask and prioritize independently
  • Represent the Quality Assurance Validation group in project teams
  • Qualifications/About You
  • Technical Validation acumen with ability to make Quality Assurance decisions
  • Expertise in Validation activities (Equipment, CQV)
  • Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
  • Bachelors' and/or Masters' degree in Engineering, Biochemistry or related field
  • Minimum of 7 years industry experience
  • Experience using risk based approaches (FMEA, PHA, etc).
  • Experience supporting internal regulatory and partner inspections.
  • Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers.
  • This is a fast moving opportunity ideally looking to implement this person ASAP. If you, or someone you know, has the skillset above, and, is interested in this role, lets connect! Please forward an updated version of your resume to the attention of Ahmed Hassan and team at Real Staffing, Boston.

Sthree US is acting as an Employment Business in relation to this vacancy.