Job Description
Summary:
The Director of Quality Control (QC) is responsible for leading the Quality Control Unit (Microbiology & Chemistry) at the site and for providing analytical technical guidance to the various site functions. Responsibilities include but are not limited to overseeing total quality control activities, including testing of raw materials, intermediates, APIs and drug products, support to production, proper life-cycle of test methods (i.e. validation, transfer, review, approval, changes), OOS/OOT investigations, stability programs and compliance to the applicable compendial, regulatory and customer requirements. The Director of Quality Control (QC) also ensures compliance of the laboratory operations to the most current data integrity requirements, drives continuous improvement activities and implementation of industry best practices in the QC laboratories to maximize efficiency while maintaining a high compliance level. The Director of Quality Control (QC) will interact wi...
The Director of Quality Control (QC) is responsible for leading the Quality Control Unit (Microbiology & Chemistry) at the site and for providing analytical technical guidance to the various site functions. Responsibilities include but are not limited to overseeing total quality control activities, including testing of raw materials, intermediates, APIs and drug products, support to production, proper life-cycle of test methods (i.e. validation, transfer, review, approval, changes), OOS/OOT investigations, stability programs and compliance to the applicable compendial, regulatory and customer requirements. The Director of Quality Control (QC) also ensures compliance of the laboratory operations to the most current data integrity requirements, drives continuous improvement activities and implementation of industry best practices in the QC laboratories to maximize efficiency while maintaining a high compliance level. The Director of Quality Control (QC) will interact wi...