Quality Control Analyst II - Raw Materials

Position Summary:

The Quality Control (QC) Analyst II - Raw Materials Group 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:

• Perform qualitative and quantitative testing of raw materials using techniques such as HPLC, GC, FTIR, UV-Vis, titration, and wet chemistry.
• Review and interpret 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.
• Manage QC incoming inspection and AQL activities related to raw material and finished products.
• Prepare and review technical documents including SOPs, test methods, and specifications.
• Investigate and document out-of-specification (OOS) results and deviations.
• Support raw material qualification and requalification programs.
• Collaborate with 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.
• 2-5 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.
• May require occasional lifting of materials up to 25 lbs.
• Use of personal protective equipment (PPE) as required.