QA Operations Specialist

QA Operations Specialist
  • $64.73 per Hour
  • Temporary
  • Lexington MA, US Lexington MIDDLESEX US 02421
Job Ref: JO000127426
Sector: Clinical
Sub-sector: Quality
Date Added: 09 January 2022

QA Operations Specialist Contractor - Lexington, MA - ON SITE WORK, NOT REMOTE:
The QA Operations Specialist Contractor will be responsible for supporting the implementation and on-going Drug Product batch documentation review and disposition. In addition, this individual will provide QA support to internal and external 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 support to external clients
• Review and approve master manufacturing batch records
• Review of executed manufacturing batch records
• Final disposition of client clinical drug product
• Disposition raw materials for Drug Product use
• Author, review and/or approve standard operating procedures and other quality documents, as needed
• Review and approve deviations, investigations, OOS/OOT results, and CAPA action plans
• Review and approve Change Controls and associated documentation
• Review and approve raw materials specifications
• Issue part numbers
• Support site metrics generation, as needed
• Ensure all documentation complies with GMP regulations and industry guidelines
• Support the development, implementation, and revision of corporate quality systems
• Review and approve other GMP documents associated with the manufacture, testing, packaging, and labeling
• Review stability documentation
• 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 0.00 64.73 Hour
Contact Consultant:
Jennifer Law

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