QC Analyst, Data Review - Ophthalmic Quality Specialist

Location: Bedford, MA (Onsite – 5 days/week)Employment Type: Full-timeDuration: Full-time (ongoing)Compensation: $68,000–$75,000/yearJob SummaryConduct detailed review of analytical chemistry and microbiology data generated for small-molecule and combination products. This position plays a key role in confirming that all QC records are accurate, complete, and fully compliant with cGMP, GLP, and ALCOA+ data integrity principles to support batch release, stability, and regulatory filings.Key ResponsibilitiesReview analytical raw data generated by HPLC/UPLC, GC, spectrophotometry, pH, dissolution, and device function/performance testingConfirm accuracy of calculations, instrument suitability, standards, sequences, and chromatographic integrationsVerify that testing follows compendial methods, validated procedures, and approved specificationsExamine microbiology data including bioburden, endotoxin, sterility, identification, environmental monitoring, and growth promotion testingEvaluate environmental monitoring trends, alert/action limit excursions, and sterility assurance recordsCheck logbooks, equipment records, audit trails, and electronic entries for completeness and ALCOA+ complianceIdentify discrepancies and collaborate with analysts to resolve findingsSupport OOS/OOT investigations through data trend and anomaly analysisMaintain audit-ready documentation and serve as a data review subject matter expert during internal and external auditsQualificationsBachelor's degree in Chemistry, Microbiology, Biochemistry, Biology, or related scientific discipline3–5 years of experience in Quality Control laboratory (analytical or microbiology) within biotech, pharmaceutical, or medical device industriesStrong working knowledge of cGMP, GLP, and data integrity expectations (ALCOA+)Experience reviewing analytical chemistry and microbiology dataFamiliarity with chromatography software (e.g., Empower) and electronic data management systems including LIMSExcellent attention to detail, organizational skills, and ability to work independentlyWhat We OfferCompetitive full-time compensation and benefitsDirect impact on product quality and regulatory compliancePlatform collaboration and support toolsHow to ApplyTo apply, visit our career portal and complete the quick and straightforward application process: enter your details, upload your CV, add your LinkedIn (optional), answer a few qualifying questions.Apply Now(Or visit:https://www.pharmasmarket.com/signup/talent