1.Coordinate, schedule and implement all aspects of the environmental quality monitoring and control and the microbiological testing for the Quality Assurance of Zimmer Manufacturing B.V. sterile products.
2.Manage 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.
3.Backup the Lab. Manager in the direct management of microbiology lab including: interviewing; hiring; planning; assigning and directing work; appraising performance; rewarding and disciplining employees; review and approval of expenditures; supervision of the installation, operation and maintenance of laboratory equipment and planning and supervision of training of laboratory technicians.
4.Initiate corrective actions for atypical results to meet regulations, guidelines and specifications.
5.Perform all testing provided by the Microbiology Service Lab. including but not limited to: bioburden, sterility, residue testing, environmental sampling/test, and chemical test on water, microorganism identification and Sterility Test.
6.Assure microbiology and chemical testing, test results and documentation are in compliance with USP, GMP, GLP Environmental Lab. procedures and other applicable regulations.
7.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 rooms design and special projects as they occur.
8.Participate in the approval of Laboratory procedures; test data; reports; supervision of installation, operation and maintenance of laboratory equipment.
9.Planning and train of laboratory personnel and other department personnel as need.
10.Write CAR ensuring that provisions are made for economically checking the precision and accuracy of the testing test methods, measurement equipment and other physical and analytical devices.
11.Introduce and implement new systems and technologies to keep pace with government regulations/guidelines and state of the art methods.
12.Conduct audits of laboratory services supplies on Zimmer Manufacturing facilities for compliance with all GMP, GLP and USP procedures, requirements and techniques.
13.Perform investigation related to microbiological and chemical test. Initiate corrective actions for atypical results to meet regulations, guidelines and specifications.
14.Design and execute laboratory equipment qualifications/validations including final report with data analysis and final recommendations.
Expected Areas of Competence
1.Must have experience in the following areas: validation of clean-room facilities, environmental monitoring, clean room techniques and development of new test methods.
2.The incumbent must have a through knowledge of validation of clean room and methods.
3.Good organization skills are required to successfully perform multiple tasks at the same time and under pressure of constant deadlines.
4.Must have excellent written and oral communication skill in Spanish and English.
5.Readily recognize and solve problems impacting diverse laboratory and manufacturing operations by formulation and implementing plans to improve laboratory productivity, improve data quality, improve analytical response time and improve customer services.
6.Establish strategies to continually evaluate performance against targets and identifies remedial actions as needed.
7.Lead continues improvements efforts by assisting in determining root cause of non conformance product, tracking trend data; identify opportunities for corrective/preventive actions.
8.Promote safety by assuring laboratory associate equipments and operating procedures are maintained to provide safe environment.
B.S. or M.S. degree in Chemistry or Biochemistry a minimum of two years of which must have involved in validation of systems and equipment and experience in supervision.