Quality Control Analyst I, Raw Materials

Key Responsibilities

• Perform routine and non-routine testing of raw materials to ensure compliance with internal specifications, regulatory requirements, and industry standards.
• 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.
• Absorb and coordinate QC incoming inspections and AQL activities related to raw material and finished products.
• Assist in the preparation and review of technical documents including SOP’s, test protocols, test reports, test methods, and specifications.
• May assist in the preparation and review of 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.

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.