QC Technical Service Scientist

QC Technical Service Scientist
  • $64.73 per Hour
  • Temporary
  • Lexington MA, US Lexington MIDDLESEX US 02421
Job Ref: JO000127424
Sector: Clinical
Sub-sector: Quality
Date Added: 09 January 2022

QC Specialist IV

- Will require on-site presence, NOT REMOTE
The QAV Specialist Contractor will be responsible for supporting Commissioning, Qualification, and Validation efforts at the Lexington Facility. This individual will be responsible for the review and approval of CQV, Method Qualification, and Technology Transfer documentation and associated quality records. In addition, this individual will provide QAV support to cross-functional teams. The ideal candidate is a self-starter with experience in an early-phase clinical manufacturing environment and have a collaborative mindset.
Location: Lexington, MA
Term: 6 months
Duties and Responsibilities
• Provide QA oversight to Commissioning, Qualification, and Validation (CQV) activities at the Lexington Facility
• Provide QA oversight to Technology Transfer projects; review and approve associated documentation
• Review and approve CQV lifecycle documentation included but not limited to: User Requirements, Risk Assessments, Plans, Protocols, and Reports
• Review and approve Method Qualification documentation
• Provide QA support and review and approval for discrepancy, deviations, and CAPAs
• Author, review and/or approve Standard Operating Procedures and other QAV documents, as needed
• Review and approve Change Controls and associated documentation
• Ensure all documentation complies with internal requirements, GMP regulations, and industry guidelines
• May serve on project teams
10+ Years Experience


SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

09/02/2022 12:00:00
USD 64.73 0.00 Hour
Contact Consultant:
Jennifer Law

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