Associate Data Reviewer

Position Title: Associate Data Reviewer

Work Location: Worcester, MA, 01604

Assignment Duration: 6 Months

Work Arrangement: 100% Onsite

Position Summary

The Associate Data Reviewer will support the QA Data Review team within a fast-paced GMP environment. The role focuses on reviewing and archiving data related to raw materials, environmental monitoring, in-process samples, final bulk, stability, and validation activities.

This position includes both administrative and technical responsibilities, with initial emphasis on archiving and potential progression to data review tasks.

Background & Context

• Part of the QA Data Review Group at the Worcester site.
• Responsibilities include reviewing validation, raw material, microbiology, analytical, bulk, and release testing data.
• The team ensures final data review and authorization prior to release.
• Two profiles are sought:
  
  
  
  1. Administrative archiving-focused.
  2. Analytical and/or microbiology data review-focused.
  
  
  
  

• Archive data in the RIMS system.
• Perform routine laboratory test data reviews, including On-the-Floor and Off-the-Floor reviews for low-complexity methods.
• Maintain compliance with GMP standards, laboratory records, procedures, and systems.
• Ensure a safe work environment for self and colleagues.
• Manage administrative tasks such as logbook control, scanning, and filing of data.
• Accept responsibility for timely completion of assigned tasks.
• Collaborate effectively to maintain a positive and productive team atmosphere.
• Support training of other employees through hands-on demonstration (not management of training delivery).

• Education:
  
  
  
  • Bachelor's degree, OR
  • High School Diploma with 5+ years of combined experience in manufacturing, QA, or QC within pharmaceutical/biologics, OR
  • Master's degree with 1-2 years of relevant industry experience (not considered overqualified).
  
  
  
  
• Strong attention to detail with excellent organizational and time management skills.
• Preferred Experience:
  
  
  
  • QC lab data review and familiarity with biologics production.
  • Laboratory experience to support data review understanding.
  • Knowledge of large, matrixed organizational environments.
  • Familiarity with RIMS (training available), Empower for analytical data review, and sample management systems.
  
  
  
  
• Physical Requirement: Ability to lift up to 10 pounds independently.