FSP – QC Reviewer – Data Review
Core
Ensuring accuracy, completeness, and compliance of analytical data and documentation for biologics products in support of product release, stability, and regulatory activities.
Role type
QC Data Reviewer
Builds
Compliance-ready data packages for biologics product release and regulatory submissions
Domain
Life Sciences / Biologics / Quality Control
Required skills
Data review and reporting, Trend analysis, Discrepancy identification, GMP knowledge, Data integrity principles, Regulatory documentation, CAPA support, Document revision, Cross-functional collaboration
Preferred skills
None stated
Technologies
None stated
Responsibilities
Perform data review and reporting for release, stability, qualification, transfer, and validation activities; Identify and escalate discrepancies and data integrity concerns; Support review metrics collection and data trending; Participate in document revisions and process harmonization; Support deviations, investigations, and CAPAs; Support regulatory submissions and inspections; Perform QC data verification to ensure accuracy and compliance.
Seniority
Mid-level (2-5 years experience)
