Data Review Specialist, Quality Control
$98,000–$113,000 year
On-siteBedford, Massachusetts, United States
Job Summary
Review analytical raw data for HPLC, GC, and microbiology to ensure accuracy, completeness, and compliance with cGMP, GLP, and ALCOA+ standards. Monitor stability and release testing trends to identify atypical results, OOT signals, and data integrity concerns requiring escalation. Collaborate with QC, QA, Manufacturing, and Supply Chain stakeholders to evaluate discrepancies, support investigations, and drive continuous improvement in data review workflows. This role supports batch release, stability studies, and regulatory submissions for Ocular Therapeutix's bioresorbable hydrogel-based therapies. Full-time position in Bedford, MA.
Required 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
- 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
Desired Qualifications
- Familiarity with statistical software, JMP preferred
- Prior experience with method validation and stability study protocols
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.