Position Summary
The Quality Control Analyst, Data Review, is responsible for thorough review of analytical chemistry and microbiology data supporting small‑molecule and combination products. This role ensures all electronic and paper QC records are complete, accurate, and compliant with cGMP, GLP, and ALCOA+ data‑integrity expectations. The position is critical for assuring reliable data used for batch release, stability programs, environmental monitoring, method validation, device testing, and regulatory submissions.
Key Responsibilities
Quality Control Data Review
• Review analytical raw data (HPLC/UPLC, GC, spectrophotometry, pH, dissolution, device function & performance testing). • Verify calculations, instrument suitability, standards, sequences, and chromatographic integration. • Ensure testing complies with compendial methods, validated procedures, and specifications. • Review microbiology data (bioburden, endotoxin, sterility, ID, EM, growth promotion, device-specific assays). • Assess EM trending data, alert/action limit excursions, and sterility assurance documentation. • Verify incubation records, media traceability, sample handling, and method compliance. • Review logbooks, equipment records, and supporting documentation for accuracy and completeness. • Review audit trails for data integrity and ALCOA+ compliance. • Confirm accurate documentation in LIMS, notebooks, and electronic systems. • Document data review comments; work with QC analysts to resolve issues.
Documentation & Compliance
Ensure reviewed data meets cGMP and FDA/EMA regulatory requirements. Conduct timely and thorough review of data packages to support lot release, stability pulls, device testing, and method verification/validation activities. Identify discrepancies and document data review comments; work with QC analysts to resolve issues. Maintain audit-ready documentation status and participate in audits as a data review SME.
Quality Systems & Continuous Improvement
Recommend and support improvements to data review workflows, documentation templates, LIMS interfaces, and data integrity practices. Participate in training efforts for analysts on proper documentation and data integrity. Support implementation or upgrades to electronic data systems, such as LIMS.
Cross-Functional Collaboration
Partner with QC Chemistry, Raw Materials, Analytical Development, QC Microbiology, QA, Manufacturing, Supply Chain, and Product Development groups. Communicate delays, data discrepancies, and potential risks to QC and QA leadership promptly. Support cross-functional data requests related to product release, investigations, validations, or regulatory submissions.
Qualifications
Bachelor's degree in Chemistry, Microbiology, Biochemistry, Biology, or related scientific discipline. 3-5 years of experience in a Quality Control laboratory (analytical or microbiology) within biotech, pharmaceutical, or medical device industries. Strong working knowledge of cGMP, GLP, and data integrity expectations (ALCOA+). Experience reviewing laboratory data for accuracy and compliance. Experience reviewing analytical chemistry and microbiology data (bioburden, endotoxin, EM trending, sterility). Familiarity with chromatography software (e.g., Empower) and microbiology testing documentation. Proficiency with electronic data management systems, including LIMS. Prior experience with method validation and stability study protocols is a plus.