Data Reviewer, Quality Control

Data Reviewer, Quality Control Your Role

The Data Reviewer, Quality Control is primarily responsible for reviewing Quality Control analytical data to ensure accuracy, compliance, and data integrity within a GMP-regulated environment.

• Conduct comprehensive and critical evaluations of QC data using Empower and Soft Max Pro software, including review of results, calculations, data accuracy, scientific relevance, formatting, and adherence to cGMP requirements

• Perform thorough reviews of raw data, including electronic raw data and documentation, to ensure compliance with specifications and protocols

• Conduct GMP reviews of laboratory notebooks, logbooks, and associated forms

• Review electronic raw data to ensure compliance with data integrity policies and 21 CFR requirements

• Support OOS (Out-of-Specification) and OOT (Out-of-Trend) investigations

• Assist with internal and external audits

• Support QC method validation reviews as needed

• Review procedural and method revisions when required

• Perform other duties as assigned to support Quality activities

• Bachelor’s degree in a life sciences field (Biology, Microbiology, Biochemistry, Chemistry, or related discipline preferred)

• 4+ years of experience in a GMP, biopharmaceutical, or pharmaceutical manufacturing environment

• Experience using Empower and Soft Max Pro software

• Knowledge of cGMP regulations, pharmacopeial, and compendial requirements

• Understanding of 21 CFR data integrity requirements

• Familiarity with analytical testing methods, method validation, and laboratory instrumentation

• Experience with laboratory computerized systems such as Empower and LIMS

• Proficiency in Microsoft Office applications

• Strong written and verbal communication skills

This is a full-time position. Standard work schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m., unless otherwise directed by the Supervisor. Flexibility to work holidays, weekends, or extended hours may be required.

The hourly compensation range for this role is $26.73–$35.62, depending on experience and qualifications. We also provide opportunities for career growth and a supportive, inclusive work environment.

• A collaborative team player with a positive, solution-oriented mindset

• A strong communicator who conveys information clearly and confidently

• Highly detail-oriented with excellent organizational and multitasking skills

• Skilled at building and maintaining professional relationships across teams and departments