Quality Control Line Chemist

Primary Purpose:

Ensure manufactured products meet strict quality, safety, and purity standards by testing raw materials, in-process samples, and finished goods against established specifications and regulatory guidelines, acting as the gatekeeper to prevent substandard products from reaching consumers and ensuring consistency across batches.

Key Accountabilities:

• Conduct quantitative and qualitative tests on raw materials, intermediates, and final products for identity, purity, potency, and stability.
• Utilize and maintain sophisticated lab equipment like HPLC, GC, UV/Vis Spectrophotometers, etc., ensuring calibration and validation.
• Develop, perform, and document method validation and verification studies.
• Accurately record all test data, review results, and generate reports for stakeholders.
• Ensure all activities comply with cGMP, GLP, and other relevant guidelines.
• Participate in internal and external audits and inspections.
• Investigate and resolve out-of-specification (OOS) or non-conforming results.
• Collaborate cross-functionally (Manufacturing, R&D, QA) to implement Corrective and Preventive Actions (CAPA).
• Identify opportunities for continuous quality improvement.
• Prepare and standardize reagents and standards.
• Maintain laboratory cleanliness, manage waste, and ensure a safe working environment.
• Operating, calibrating, and maintaining laboratory equipment like HPLC, GC, and spectrophotometers.
• Maintaining a safe and organized laboratory environment by following safety protocols and waste disposal procedures.
• Potentially training junior staff on techniques and procedures.

Education:

A Bachelor Degree in Science or Chemical engineering.