A QC Chemist with vendor approval responsibilities in the pharmaceutical industry ensures the quality of raw materials and finished products by performing chemical tests, documenting results, and participating in vendor audits and approvals. They also maintain laboratory instruments, adhere to GMP standards, and contribute to continuous improvement initiatives.
Key Responsibilities:
· Testing and Analysis:
Perform chemical and physical analysis of raw materials, in-process samples, and finished products to ensure they meet quality standards and specifications.
· Documentation:
Maintain accurate and complete records of testing procedures, results, and deviations.
· Instrument Maintenance:
Operate, calibrate, and maintain laboratory instruments, ensuring their accuracy and reliability.
· Vendor Audits:
Participate in vendor audits, evaluate vendor performance, and approve or disapprove vendors based on audit results.
· GMP Compliance:
Adhere to Good Manufacturing Practices (GMP) guidelines and regulations.
· Problem Solving:
Investigate and resolve any quality issues or deviations identified during testing or audits.
· Collaboration:
Collaborate with other departments, including quality assurance, manufacturing, and purchasing, to ensure product quality and compliance.
Key Skills and Qualifications:
· Bachelor's or Master's degree in Chemistry or related field.
· Experience in quality control, particularly in a pharmaceutical or biotechnology setting.
· Strong knowledge of analytical chemistry, instrumentation, and analytical techniques.
· Experience with GMP guidelines and regulations.
· Strong analytical, problem-solving, and communication skills.
· Ability to work independently and as part of a team.