Responsible for the coordination of Laboratory services provided for Zimmer Manufacturing. Provide guidance and leadership in the upgrading of test methods, procedures and equipment for environmental and microbiological control and sterilization. Responsible for operating and maintaining laboratory equipment and for accurately recording results of tests within the assigned laboratory. Manage quality programs required to support, evaluate, document and audit the microbiological and environmental control programs at Zimmer Manufacturing. Support the implementation and maintenance of Quality System Regulation and ISO Standard provisions at all levels in the organization.
Principal Duties and Responsibilities
- Performs tests, experiments, required maintenance of laboratory equipment and machinery..
- Coordinate, schedule and implement all aspects of the environmental quality monitoring, chemical and control and the microbiological testing for the Laboratory.
- Coordinate the daily operation of the microbiology laboratory to assure microbiology and chemical testing, test results and documentation are in compliance with USP, GMP, GLP, Environmental Lab Procedures and other applicable regulations.
- Provide technical guidance to Quality Assurance and Manufacturing on matters pertaining to microbiological/ environmental control and product sterilization such as: new manufacturing process development, validations, clean room design, operation and special projects as they occur.
- Assist the manager with the supervision of microbiology Laboratory including: interviewing; hiring; planning; assigning and directing work; appraising performance; rewarding and disciplining employees; review and approval of all lab procedures; test data; reports and expenditures; supervision of the installation, operation and maintenance of laboratory equipment and planning and supervision of training of laboratory technicians.
- Train Laboratory personnel in the Laboratory Procedures and other applicable personnel in contamination control..
- Introduce and implement new systems and technologies to keep pace with government regulations/guidelines and state of the art methods.
- Conduct audits of laboratory services supplies and Zimmer Manufacturing facilities for compliance with all GMP, GLP and USP procedures, requirements and techniques.
- Initiate corrective actions for atypical results to meet regulations, guidelines and specifications.
- Design and execute laboratory equipment qualifications including final report with data analysis and final recommendations.
Expected Areas of Competence
Must have experience in the following areas: validation of clean-room facilities, environmental monitoring, clean room techniques. Must have a thorough knowledge of medical device regulations. Must possess excellent written and oral communication skills in Spanish and English. Good interpersonal skills and teamwork oriented. Demonstrate ability , coaching, motivate, discipline, and coordinate Laboratory work.
Education/Experience Requirements
B.S. or M.S. degree in Microbiology minimum of five years in industrial microbiology, two years of which must have involved supervision of an industrial microbiology lab.
Travel Requirements
5%