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QA Batch Record Reviewer

QA Batch Record Reviewer

SPECTRAFORCEWestborough, Massachusetts, United States
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Position Title : QA Batch Record Reviewer

Work Location : Westborough, MA 01581

Assignment Duration : 5+ Months (possible extension)

Work Arrangement : Onsite; Must be Local

Position Summary : The Compliance Specialist CMC, Quality Assurance will perform critical QA tasks in support of GMP and non-GMP manufacturing programs and Regulatory Submissions at our organization.

Background & Context :

  • The successful candidate will foster data integrity, quality and compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts at our organization to help ensure high quality standards and value delivery for our patients.

Key Responsibilities :

  • Performs QA review of executed development studies intended for regulatory submissions, included but not limited to draft batch records, analytical test records, and calibration records to ensure Developmental studies are conducted and data collected in compliance with approved protocols, appropriate Corporate guidelines, internal procedures, domestic and global regulatory guidelines and standards.
  • Identifies and reports documentation errors and deviations from Protocols, SOPs or specifications in a timely manner.
  • Responsible for communicating QA review, audit results and reporting.
  • Collaborates with cross-functional stakeholders regarding quality events, ensuring quality records are clearly written and technically sound with supporting evidence.

    • Qualification & Experience :

  • BS / BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Masters degree.
  • In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and / or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.
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    Batch • Westborough, Massachusetts, United States

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