QC batch reviewer
Core
Reviewing QC batch records, analytical data, deviations, and investigations to ensure compliance with cGMP requirements and support the timely release of pharmaceutical products.
Role type
Quality Control Batch Reviewer
Builds
Pharmaceutical products
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP regulations knowledge, analytical data review (HPLC, flow cytometry, cell counting, UV/Vis spectroscopy, microbiological testing), discrepancy identification, root cause analysis, CAPA activities, audit support
Preferred skills
Electronic document management systems (EDMS), ERP systems
Responsibilities
Perform comprehensive reviews of QC batch records and analytical data; Identify and escalate discrepancies and non-conformances; Collaborate with QA and Manufacturing teams to resolve quality issues; Maintain audit-ready documentation; Participate in root cause investigations and CAPA activities; Support internal and external audits
Seniority
Mid-level, hands-on IC