Job Title: MICROBIOLOGY MANAGER - Express Interest to: dapple@appleassoc.com
Location: Missouri
Salary: $80000 - $100000
Recruit and hire competent, technically trained people for the Microbiological area. · Supervise the activities of the Microbiological staff. · Establish and implement procedures needed to carry out and validate cleaning procedures. · Establish procedures for investigations which determine the sources of microbial contamination. · Establish procedures for validating all testing procedures used in the Microbiological Laboratory. · Develop procedures for evaluating current and proposed water systems and recommend corrective action plans needed to keep water quality at an acceptable level. · Develop procedures for evaluating the air quality of the working areas. · Develop programs and schedules for Microbiological audits of subcontractors, vendors and outside testing laboratories. · Assist Director, Quality Control in identifying areas where improvements can be made in the Quality Organization with respect to innovations, elimination of non-value added activities and productivity gains. · Provide training, motivation and opportunity for personal growth and advancement for the Microbiological staff. · Actively participate in providing a safe working environment for the staff. · Assist in Regulatory inspections where required. · Interact with Research and Development, and Regulatory Affairs in new product development where required. · Assist the Director, Quality Control in establishing educational and developmental programs that will help to establish company as a World Class Manufacturer. · Act as a consultant in areas of Microbiology assays, data interpretation and balancing good science with good business, and introduce appropriate new technology to the lab. · Establish and implement systems in the Microbiology lab that will eliminate/minimize the risk of inspectional observation from the FDA. · Perform additional duties as requested or required. Job Specifications: Knowledge/Skills/Abilities Ø Knowledgeable in Microbiological Quality Control Test Procedures and all applicable State, Federal and Corporate requirements. Knowledge of USP, EP, JP and other compendial methods and use of equipment related to performing microbiological testing methods. Ability to work with little supervision. Computer proficiency. Mathematical ability. Education/Experience BS or BA in Biology/Microbiology Ø Have a minimum of 7 years experience in Microbiological Quality Control Laboratories in a Pharmaceutical manufacturing environment. Experience in supervising the activities of analysts and technicians.
Express Interest to: dapple@appleassoc.com
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