Job Description
Supervises analytical laboratory testing. Conducts and documents OOS investigations. Drafts new procedures and/or changes to SOP’s to keep current or improve cGMP status. Ensures conformance of all laboratory activities to appropriate cGMPs. Enforces compliance to regulatory, safety procedures and the Chemical Hygiene Plan. Develops, recommends, and implements systems, processes, activities, SOPs, etc. to improve quality of analytical results. Ensures that lab documents and lab data (paper and electronic) are properly classified, controlled, and stored. Conducts cGMP and on-the-job training of QC personnel. Performs analysis of samples as required. Provides training of analytical personnel on each new method and new equipment. Ensures that all lab instruments are functional and suitable through coordinating preventive maintenance, troubleshooting, appropriate calibration, instrument upgrades, etc. Coordinates maintenance/repairs with internal and external sources. Evaluates and recommends analytical instrumentation and associated equipment. Acts as liaison to vendors and outside laboratories regarding instrumental analysis/methods. Ensures that polices, safety rules, FSMA standards and GMP’s are followed and enforced and that continual improvement is made towards an injury free environment. Actively participates in root cause analysis and other continuous improvement initiatives. Recommends and implements continuous improvement ideas. Ensures key performance indicators in the analytical quality area are met or exceeded. Measures productivity on a daily basis, with goal of meeting standards. Supports positive employee relations, fair treatment and respect in all aspects of interaction with employees; address employee concerns/requests in a timely and caring manner; ensures all employees and ideas are respected and valued and their uni