Position Title: Associate Data Reviewer Work Location: Worcester, MA, 01604 Assignment Duration: 6 Months Work Arrangement: 100% OnsitePosition 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:
- Administrative archiving-focused.
- Analytical and/or microbiology data review-focused.
Key Responsibilities
- 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).
Qualifications & Experience
- 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.