Data Reviewer, Analytical Development
$80,000–$90,000 year
On-siteVerona, Wisconsin, United States
Job Summary
Conduct independent technical reviews of internal and external laboratory data to ensure compliance with analytical methods, specifications, and GMP/GDP requirements. Evaluate data for accuracy and completeness, independently investigate discrepancies, and document atypical results to determine impact and drive appropriate resolution. Review routine release, stability, method validation, IPC, cleaning samples, and logbooks for traceability while collaborating with laboratory staff and CDMOs to resolve data quality issues. Support audit readiness activities, maintain knowledge of laboratory systems, and provide guidance to junior reviewers on review practices and documentation standards.
Required Qualifications
- Bachelor's degree in chemistry or (any STEM degree)
- 5+ years GMP experience
- Master of Science (STEM degree) with minimum 3 years of experience in a cGMP laboratory (pharmaceutical CMO/CRO)
- Experience with analytical data review and documentation practices
- Working knowledge and experience with chemistry analytical methods such as HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry and microbiology testing
- Working knowledge of GMP/GDP and laboratory systems
- Candidates must have current, valid authorization to work in the country where this role is located
Desired Qualifications
- Working knowledge of USP, ISO, FDA and ICH guidelines
- Familiarity with laboratory information systems, LIMS
- Strong verbal and written communication skills and ability to work with diverse professionals in a matrix environment
- Solid organizational skills with ability to adapt to changing priorities and deadlines
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.