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.

Key Responsibilities

• Conduct comprehensive and critical evaluations of QC data using Empower and SoftMax 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

Minimum Qualifications

• 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 SoftMax 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

Position Type / Expected Hours

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.

Compensation

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.

Who You Are

• 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