QA Documentation Specialist
Lexington, MA | Contract
Duration: 6 Months +
Location: Cambridge, Massachusetts
Top 3 Technical Skills:
• GMP Quality Assurance (QA) Doc Experience
• Any experience with Technical documentation writing and/or revision
• SOP and/or Batch Record Documentation Experience
• The Quality Assurance Documentation Specialist will be responsible for the review and approval of all documentation related to late phase and commercial manufacturing to ensure timely review and disposition of client batches/lots.
• The QA Documentation Specialist will review and approval includes manufacturing batch record reviews, internal records, client records, and master batch records.
• Support conditional and final GMP release activities for disposition of bulk drug substance and drug product.
• Support external client review and resolution of comments for assigned project(s).
• Represent QA in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution.