Job Description

The QC manager will direct all laboratory activities, manage and coaches members of QC lab, execute investigations, support analytical activities, investigate method performance, prepare and reviews technical documents, ensure that high standards of safety and regulatory and other assigned duties. This is a full-time position, predominantly in a manufactory and office environment. Primary Duties and Responsibilities: • Independently manages all laboratory activities for assigned functions and projects. This is included developing timelines; daily (and longer-term) work plans, assignments and preparing reports. • Supports analytical activities such as: method validations, method development, method transfers from other sites/departments, method enhancements for API & final products, method evaluations prior to transfers, USP method verifications. • Prepares and reviews technical documents including validation protocols and reports, reference standard qualification reports, analytical test procedures, certificates of analysis, technical reports and writes investigations and deficiency reports. • Standardizes processes throughout the laboratory. Enforces compliance to cGMP's and SOP's. • Audits and reviews laboratory data generated by QC members. • Coordinates laboratory equipment qualifications, calibrations and preventative maintenance programs as needed. • Collaborates with colleagues in Research & Development and regulatory affairs.