Quality Control Stability Analyst Jobs (NOW HIRING)

Position Summary:

The Data Review Specialist will apply strong technical knowledge of laboratory operations, analytical data review, data integrity requirements, and quality systems to perform thorough reviews of analytical chemistry, microbiology, stability, and release testing data for accuracy, completeness, scientific soundness, and compliance with cGMP, GLP, and ALCOA+ expectations. This position is critical for supporting batch release, stability studies, environmental monitoring, method validation, and device testing.

In addition to data review, this role will support QC data monitoring activities, including evaluation of release data, raw material testing data, and stability data trends to identify emerging patterns, atypical results, potential OOT signals, and opportunities for improved product understanding. The Data Review Specialist will serve as a trusted partner to QC, QA, Stability, Manufacturing, Supply Chain, and Analytical Development stakeholders.

Key Responsibilities:

Quality Control Data Review

• Review analytical raw data (HPLC/UPLC, GC, spectrophotometry, pH, dissolution, device function & performance testing) to ensure accuracy in calculations, instrument suitability, standards, sequences, and chromatographic integration.
• Review microbiology data (bioburden, endotoxin, sterility, ID, EM, growth promotion, device-specific assays)
• Review and support trending of stability data across applicable drug products, raw materials, and device-related attributes to identify emerging trends, atypical results, potential OOT signals, and data patterns requiring escalation.
• Assist with interpretation of stability data in support of timepoint completion, stability reports, annual product reviews, regulatory submissions, and product lifecycle monitoring.
• Support monitoring of released testing data for commercial and clinical batches, including review of assay, impurities/degradation products, dissolution/drug release, microbiological, and device performance data where applicable.
• Collaborate with QC Stability, Raw Materials, QA, Manufacturing, Supply Chain, and Analytical Development to evaluate data trends and determine whether observed patterns require investigation, CAPA, procedural updates, or enhanced monitoring.
• Support trending and monitoring of raw material data, including supplier lot-to-lot variability, retest/expiry data, CoA verification trends, and recurring analytical or documentation issues.

Documentation & Compliance

• Ensure reviewed data packages meet cGMP, GLP, FDA/EMA, internal SOP, ALCOA+, and data integrity expectations for lot release, stability, raw materials, device testing, method validation, and regulatory support. Conduct timely and thorough review of data packages to support lot release, stability pulls, device testing, and method verification/validation activities.
• Identify and document discrepancies, atypical results, potential data integrity concerns, and review comments; work with QC, QA, and originating groups to resolve issues in a timely manner.
• Support OOS, OOT, deviations, CAPAs, audits, APR/PQR inputs, and regulatory requests by evaluating analytical, microbiological, stability, release, and raw material data for trends, anomalies, or potential root causes.

Quality Systems & Continuous Improvement

• Recommend and support improvements to data review workflows, documentation templates, JPM, LIMS/Empower interfaces, Smartsheet trackers, and data integrity practices.
• Generate and maintain reports, trackers, dashboards, and KPIs to support QC management review, workload visibility, product quality monitoring, and continuous improvement initiatives.
• Serve as a technical resource to QC analysts by reinforcing best practices in documentation, audit trail review, ALCOA+ expectations, data monitoring, and inspection readiness

Cross-Functional Collaboration

• Work cross-functionally 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.
• 5+ years in a QC laboratory, or data review role or a similar GMP-regulated environment, with a track record of strong performance, reliability, and increasing responsibility.
• Strong working knowledge of cGMP, GLP, and data integrity expectations (ALCOA+).
• Ability to independently review laboratory data, identify discrepancies, and collaborate effectively with peers and stakeholders to resolve issues in a timely manner.
• 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 JPM, LIMS, Smartsheets and Empower.
• Familiarity with statistical software, JMP preferred.
• Prior experience with method validation and stability study protocols is a plus.

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