QC Analyst, Data Review - Ophthalmic Quality Specialist

QC Analyst, Data Review - Ophthalmic Quality Specialist at Pharmas Market QC Analyst, Data Review - Ophthalmic Quality Specialist at Pharmas Market in Carlisle, Massachusetts Posted in 1 day ago.

Type:

full-time

Job Description:

Location:

Bedford, MA (Onsite - 5 days/week)

Employment Type:

Full-time Duration:

Full-time (ongoing)

Compensation:

$68,000-$75,000/year Job Summary Conduct 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 Responsibilities Review analytical raw data generated by HPLC/UPLC, GC, spectrophotometry, pH, dissolution, and device function/performance testing Confirm accuracy of calculations, instrument suitability, standards, sequences, and chromatographic integrations Verify that testing follows compendial methods, validated procedures, and approved specifications Examine microbiology data including bioburden, endotoxin, sterility, identification, environmental monitoring, and growth promotion testing Evaluate environmental monitoring trends, alert/action limit excursions, and sterility assurance records Check logbooks, equipment records, audit trails, and electronic entries for completeness and ALCOA+ compliance Identify discrepancies and collaborate with analysts to resolve findings Support OOS/OOT investigations through data trend and anomaly analysis Maintain audit-ready documentation and serve as a data review subject matter expert during internal and external audits Qualifications Bachelor's degree in Chemistry, Microbiology, Biochemistry, Biology, or related scientific discipline 3-5 years of experience in 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 analytical chemistry and microbiology data Familiarity with chromatography software (e.g., Empower) and electronic data management systems including LIMS Excellent attention to detail, organizational skills, and ability to work independently What We Offer Competitive full-time compensation and benefits Direct impact on product quality and regulatory compliance Platform collaboration and support tools How to Apply To apply, visit our career portal and complete the quick and straightforward application process: enter your details, upload your CV, add your (optional), answer a few qualifying questions. (Or visit: https://www.pharmasmarket.com/signup/talent)