Job Title: Quality Control Manager
Reports To: VP Quality
This position is primarily responsible for directing and supervising the Quality Control department by performing the following duties.
Four year college degree or master degree; and five to ten years related experience and/or training; or equivalent combination of education and experience.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Oversees the Quality Control and Method Development department operation.
Approves Quality Control test methods.
Approves Raw material and Product Specifications
Reviews and approves the Certificate of Analysis for raw materials and finished bulk product.
Generate or Review & Approve cleaning and method verification / validation protocols.
Generate or Review & Approve stability protocols.
Assists management during FDA, other regulatory, and Customer inspections.
Ensures compliance with Good Manufacturing Practices (GMP) regulations and Good Laboratory Practices (GLP) while maintaining GLP as per current industry trends and agency expectations.
Governs overall performance of the lab ensuring compliance with pre-established guidelines.
Responsible for providing training to the personnel (Chemists and Supervisors) employed.
Works very closely with Compliance and New Products department for new raw materials and products.
Maintain monthly inventory on supplies for QC lab for reagents and standards.
Verify stock of chemicals, solvents and other lab items and purchase of supplies and equipment.
Coordinates and schedules timely analytical services like release of raw materials, bulk products, finished products, R & D samples, and stability samples.
Follows up with contract laboratories for test results
Performs other duties as assigned.
Hands-on experience in modern analytical instruments, such as HPLC, GC, ICP-MS etc.
Knowledge in microbiological analysis.