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 unique and diverse perspectives are leveraged to improve business results. Actively engages in the performance of his/her team through setting objectives and measuring performance. Serves as a coach and mentor to ensure the ongoing development of his/her team. Complies with safety and GMP requirements. SAFETY RESPONSIBILITY STATEMENT Supports a culture of safe production and exhibits safe work practices. Actively participates in the safety program by engaging in safety activities. Effectively provides and accepts constructive peer-to-peer feedback on safety performance. Adheres to policies, procedures, SOP’s, safe work practices, and safety policies and procedures (SPP). Reports ALL workplace incidents to manager immediately. Communicates concerns to manager, reports hazards, and provides input on prevention. Properly uses, wears, and stores Personal Protective Equipment when required. Participates on safety teams and/or completes safety-related activities as part of regular job responsibilities. Responsible for safe work performance in area. Ensures the completion of job safety analyses, safety inspections and employee training. Acts as primary communicator of safe work practices and information to department. Facilitates employees’ participation in the safety activity card program and on safety teams. Completes incident investigation reports and submits them to manager by end of shift on which the incident is reported. Conducts safety contacts and documents corrective and preventative actions. Enforces company policies, procedures, SOP’s, SPP’s and safe work practices. Supervisory Responsibilities Directly supervises analytical lab chemists and analytical lab technicians on the shift. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training, employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems.
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Job Type
Full-time
Career Level
Mid Level