Senior QC Data Reviewer
Core
Independent review of analytical and microbiological data generated for release, stability, raw material, validation, and method transfer activities to ensure accuracy, traceability, and GMP compliance.
Role type
Senior QC Data Reviewer (GMP)
Builds
Clinical development programs for antibody-based medicines
Domain
Biotechnology / Pharmaceutical Quality Control
Required skills
GMP compliance, ALCOA+ data integrity, OOS/OOT investigation, CAPA, analytical data review (HPLC/UPLC, GC, UV/Vis, spectroscopy, wet chemistry), microbiological data review, method validation/qualification/verification, deviation management, root cause analysis, regulatory submission support, laboratory systems (Empower, LIMS)
Preferred skills
QA experience, independent decision-making, coaching analysts on documentation practices, inspection and audit readiness
Technologies
Empower, LIMS, HPLC, UPLC, GC, UV/Vis, spectroscopy, ELISA, CE-SDS, iCIEF
Responsibilities
Perform independent GMP review of analytical and microbiological data from internal and external labs; Verify calculations, sample identification, and acceptance criteria; Escalate OOS, OOT, and data irregularities; Ensure data integrity per ALCOA+ principles; Review data for method development and validation activities; Partner with scientists to resolve documentation gaps; Provide technical judgment for investigations and CAPAs; Review Certificates of Analysis and stability reports; Support regulatory submissions and SOP development; Drive continuous improvement in QC processes.
Seniority
Senior, hands-on IC