Quality Control Analyst I, Raw Materials

Ocular Therapeutix • Bedford, MA

1d • Onsite

About The Position

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.

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 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.

Nice To Haves

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

Responsibilities

• Performing qualitative and quantitative testing of raw materials using techniques such as HPLC, GC, FTIR, UV-Vis, titration, and wet chemistry.
• Review and interpretation of analytical data, ensuring accuracy and compliance with cGMP, USP, EP, JP, and other applicable standards.
• Aliquoting, shipment and coordinating the external outsourced testing of raw materials at contract laboratories.
• Managing QC incoming inspections and AQL activities related to raw material and finished products.
• Preparation and review of technical documents including SOP’s, test protocols, test reports, test methods, and specifications.
• Method transfer, validation and verification activities per ICH Q2/ cGMP guidelines.
• Investigating and documenting out-of-specification (OOS) results and deviations.
• Supporting raw material qualification and requalification programs.
• Collaborating with quality assurance, procurement, warehouse, and manufacturing teams to resolve material-related issues.
• Participating in internal and external audits and inspections.
• Ensuring laboratory safety and compliance with environmental and regulatory guidelines.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 101-250 employees