Quality Control Analyst I, Raw Materials
Ocular Therapeutix, Inc.
August 22, 2026
On-site
Bedford, MA
Operations
Position Summary
Quality Control (QC) Analyst I, Raw Materials is responsible for routine and non-routine testing of raw materials to ensure compliance with internal specifications, regulatory requirements, and industry standards. Performs analytical testing, documentation, and cross-functional collaboration to support manufacturing and supply chain operations.
Key Responsibilities
- Perform qualitative and quantitative testing of raw materials using HPLC, GC, FTIR, UV-Vis, titration, and wet chemistry.
- Review and interpret analytical data; ensure compliance with cGMP, USP, EP, JP, and other applicable standards.
- Support aliquoting, shipment, and coordination of outsourced testing at contract laboratories.
- Assist with QC incoming inspections and AQL activities for raw materials and finished products.
- Assist in preparation/review of SOPs, test protocols, test reports, test methods, and specifications.
- Perform method transfer, validation, and verification per ICH Q2 and cGMP guidelines.
- Investigate and document out-of-specification (OOS) results and deviations.
- Support raw material qualification and requalification.
- Collaborate with QA, procurement, warehouse, and manufacturing to resolve material-related issues.
- Participate in internal and external audits/inspections; ensure lab safety and environmental/regulatory compliance.
Qualifications
- Bachelor’s degree in Chemistry, Biochemistry, or related scientific discipline.
- 1–3 years QC laboratory experience (regulated industry preferred).
- Proficiency with analytical techniques and instrumentation.
- Strong understanding of cGMP and GLP/regulatory guidelines.
- Excellent documentation/organizational skills; ability to work independently and in a team.
- Strong problem-solving/critical thinking.
Preferred Qualifications
- Experience with LIMS.
- Familiarity with compendial testing (USP, EP, JP).
- Knowledge of raw material lifecycle management.
Work Environment
- Laboratory setting with chemicals and analytical instruments; occasional lifting up to 25 lbs; use of PPE as required.
Salary Range
$68,000–$75,000 USD
Quality Control (QC) Analyst I, Raw Materials is responsible for routine and non-routine testing of raw materials to ensure compliance with internal specifications, regulatory requirements, and industry standards. Performs analytical testing, documentation, and cross-functional collaboration to support manufacturing and supply chain operations.
Key Responsibilities
- Perform qualitative and quantitative testing of raw materials using HPLC, GC, FTIR, UV-Vis, titration, and wet chemistry.
- Review and interpret analytical data; ensure compliance with cGMP, USP, EP, JP, and other applicable standards.
- Support aliquoting, shipment, and coordination of outsourced testing at contract laboratories.
- Assist with QC incoming inspections and AQL activities for raw materials and finished products.
- Assist in preparation/review of SOPs, test protocols, test reports, test methods, and specifications.
- Perform method transfer, validation, and verification per ICH Q2 and cGMP guidelines.
- Investigate and document out-of-specification (OOS) results and deviations.
- Support raw material qualification and requalification.
- Collaborate with QA, procurement, warehouse, and manufacturing to resolve material-related issues.
- Participate in internal and external audits/inspections; ensure lab safety and environmental/regulatory compliance.
Qualifications
- Bachelor’s degree in Chemistry, Biochemistry, or related scientific discipline.
- 1–3 years QC laboratory experience (regulated industry preferred).
- Proficiency with analytical techniques and instrumentation.
- Strong understanding of cGMP and GLP/regulatory guidelines.
- Excellent documentation/organizational skills; ability to work independently and in a team.
- Strong problem-solving/critical thinking.
Preferred Qualifications
- Experience with LIMS.
- Familiarity with compendial testing (USP, EP, JP).
- Knowledge of raw material lifecycle management.
Work Environment
- Laboratory setting with chemicals and analytical instruments; occasional lifting up to 25 lbs; use of PPE as required.
Salary Range
$68,000–$75,000 USD