Quality Specialist (Analytical Data Review)

Job Responsibilities

• Perform comprehensive review of batch records, GMP documentation (deviations, OOS, OOT, LIR, CAPA, Change Controls, validation reports, and COAs), ensuring completeness, accuracy, and compliance prior to batch release or rejection.
• Evaluate QC analytical data, audit trails, raw data, chromatograms, spectra, and results from laboratory systems (HPLC, GC, LIMS) to verify compliance with approved methods, specifications, and ALCOA+ data integrity principles.
• Review manufacturing and packaging activities against approved BMR/BPR, ensuring step-by-step procedure compliance and identifying deviations or discrepancies.
• Provide QA support on the production floor during manufacturing, investigations, and critical operations.
• Participate in investigations related to deviations, OOS, OOT, and quality events; ensure timely closure with appropriate root cause analysis and review of effectiveness checks.
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