Quality Control Analyst I, Raw Materials

About the role

Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. The Quality Control (QC) Analyst I, Raw Materials performs routine and non-routine testing of raw materials to ensure compliance with internal specifications, regulatory requirements, and industry standards. This role supports manufacturing and supply chain operations through analytical testing, documentation, and cross-functional collaboration.

Responsibilities

• Perform qualitative and quantitative testing of raw materials using techniques such as HPLC, GC, FTIR, UV-Vis, titration, and wet chemistry.
• Support the review and interpretation of analytical data, ensuring accuracy and compliance with cGMP, USP, EP, JP, and other applicable standards.
• Support aliquoting, shipment, and coordination of external outsourced testing of raw materials at contract laboratories.
• Assist in managing QC incoming inspections and AQL activities related to raw materials and finished products.
• Assist in the preparation and review of technical documents including SOPs, test protocols, test reports, test methods, and specifications.
• Perform method transfer, validation, and verification activities per ICH Q2/cGMP guidelines.
• Investigate and document out-of-specification (OOS) results and deviations.
• Support raw material qualification and requalification programs.
• Collaborate with quality assurance, procurement, warehouse, and manufacturing teams to resolve material-related issues.
• Participate in internal and external audits and inspections.
• Ensure laboratory safety and compliance with environmental and regulatory guidelines.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline.
• 1–3 years of experience in a QC laboratory, preferably in a regulated industry.
• Proficiency in analytical techniques and instrumentation.
• Strong understanding of cGMP, GLP, and regulatory guidelines.
• Excellent documentation and organizational skills.
• Ability to work independently and in a team environment.
• Strong problem-solving and critical-thinking abilities.

Preferred Qualifications

• Experience with LIMS.
• Familiarity with compendial testing (USP, EP, JP).
• Knowledge of raw material lifecycle management.

Work Environment

• Laboratory setting with exposure to chemicals and analytical instruments.
• Occasional lifting of materials up to 25 lbs.
• Use of personal protective equipment (PPE) as required.

Pay

$68,000 USD - $75,000 USD