Data Reviewer, Quality Control

Role: Data Reviewer in a biopharmaceutical GMP laboratory, responsible for independently reviewing laboratory data to ensure compliance with analytical methods, specifications, and GMP standards. Primary objectives include evaluating data accuracy, completeness, and quality; investigating discrepancies; supporting inspection readiness; and contributing to process improvements. Responsibilities encompass reviewing routine release and stability data, method validation reports, and logbooks; collaborating with laboratory staff and CDMOs; and mentoring junior reviewers. Requirements include a Bachelor’s degree in chemistry or STEM with 5+ years GMP experience, or a Master’s with at least 3 years of GMP laboratory experience; familiarity with analytical techniques such as HPLC, GC, LC-MS, and microbiology testing; and knowledge of GMP/GDP standards. Preferred qualifications are familiarity with USP, ISO, FDA, ICH guidelines, laboratory information systems (LIMS), and strong communication skills. The role supports Arrowhead’s platform in RNA interference therapeutics targeting genetic diseases, with a focus on analytical data integrity crucial for clinical and manufacturing stages. The position is based in Wisconsin with salary range $80,000–$90,000 USD, and candidates must have valid authorization to work in the U.S.