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Job #02656

About our client Our client is a biopharmaceutical company based in Wisconsin. They are known worldwide as the supplier of high-quality pharmaceutical ingredients. The company has been a leader in its field of expertise for the last 3 decades. It has premier investors, an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Group Leader – Calibration Waunakee, Wisconsin Salary Highly competitive package, commensurate with experience Responsibilities 1) Execute metrology program requirements to ensure that proper calibration of production, research and quality control instruments, and processes are met 2) Develop and maintain cGMP – compliant metrology systems 3) Work with department Manager to determine scheduling as per company priorities and ensure that the cGMP calibration schedule is met 4) Develop appropriate calibration systems and procedures for new and existing process and/or lab equipment 5) Oversee/Perform calibration of a wide variety of electronic, pneumatic, physical, dimensional and analytical measuring instruments to include a diverse range of disciplines such as recorders, controllers, transducers, etc. 6) Review calibration records to determine if the calibration range used for the process was correct, met specifications and GMP standards, as well as watch for trends, if any and correct tolerance used 7) Assess Out of Tolerance (OOT) results along with determining how the OOT affects the product and write a report explaining the justification 8) Write technical reports, develop charts, graphs and schematics to describe and illustrate the operating characteristics of instrumentation that may also include malfunctions, deviations and functional limitations 9) Review the USP monographs and determine how the applicable changes affect company calibrations 10) Participate in audits, address audit findings, and write studies and investigations (where necessary) 11) Prepare and/or approve calibration SOPs and verify that if they are completed in a timely manner 12) Provide training to other departments’ personnel on calibration-type procedures to be performed by the other departments 13) Train and qualify calibration personnel on cGMP calibration requirements 14) Oversee contractor third-party calibration 15) Perform all aspects of metrology and calibration to maintain various calibration standards, the Calibration and Metrology Information System (CMIS) 16) Provide written recommendations to the management in support of it 17) Perform duties with a sense of immediacy 18) Act proactively to ensure regulatory compliance posture 19) Perform other duties as assigned Requirements 1) Bachelor’s degree in Physical Science, Metrology, Electronics or a related field/applicable training and direct work experience 2) 5+ years of experience in a pharmaceutical GMP lab or production setting 3) Minimum 2 years of GMP supervisory experience 4) Familiarity with equipment functionality 5) Ability to take initiatives as well as use good judgment 6) Computer skills with database systems, spreadsheets and word processing 7) Exceptional communication (oral and written) skills, especially in technical writing 8) Excellent organizational skills 9) Good attendance