Quality Control Analyst I, Raw Materials

Quality Control Analyst I, Raw Materials Ocular Therapeutix - 3.8 Bedford, MA Job Details $68,000 - $75,000 a year 11 hours ago Qualifications GLP Laboratory instruments Regulatory compliance GMP Laboratory quality control Quality standards in production Full Job Description 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™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space. Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.

Position Summary:

The Quality Control (QC) Analyst I, Raw Materials is responsible for performing routine and non-routine testing of raw materials to ensure compliance with internal specifications, regulatory requirements, and industry standards. This role involves analytical testing, documentation, and collaboration with cross-functional teams to support manufacturing and supply chain operations.

Key Responsibilities:

The primary responsibilities of this role will be performing 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 coordinating the external outsourced testing of raw materials at contract laboratories. Assist in managing QC incoming inspections and AQL activities related to raw material and finished products. May assist in the preparation and review of technical documents including SOP's, test protocols, test reports, test methods, and specifications. May perform method transfer, validation and verification activities per ICH Q2/ cGMP guidelines. May 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.

Qualifications:

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 is required. Proficiency in analytical techniques and instrumentation is required. Must have a 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. May require occasional lifting of materials up to 25 lbs. Use of personal protective equipment (PPE) as required. #LI-LM1 Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.