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SR CALIBRATION SPECIALIST

Fresenius Kabi USA, LLC
life insurance, 401(k)
United States, North Carolina, Wilson
5200 Corporate Pkwy (Show on map)
Feb 22, 2025
Job Summary The Sr. Calibration Specialist is responsible for performing the calibration and repair of various instrumentation within the facility that is used for monitoring both Critical and Non-Critical process parameters related to various manufacturing and support functions used to determine Quality decisions. Will provide mentoring of junior metrology personnel. Actively participate in the coordination of calibration activities in order to meet established Quality, regulatory and customer requirements. Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT.

  • Calibrate / maintain process and analytical instrumentations according to site SOP's.
  • Coordinate vendor calibrations for on-site or off-site calibration service.
  • Review and approve both vendor and internal calibration documents ensuring compliance to site standard operating procedures.
  • Maintain orderly, accurate, and accessible records of calibration maintenance and repairs performed on all instruments in compliance with cGMP/cGLP requirements.
  • Prepare / revise instrument calibration and preventive maintenance SOP's for new and existing instruments.
  • Distribute monthly calibration schedules generated from the calibration data management system to Operation and/or Production Management and department supervisors.
  • Review the status of Metrology standards to ensure proper operation and current calibration status.
  • Perform weekly review of the metrology area compliance to Site 5S standards.
  • Ensure the proper storage of metrology's standards, tools, and other equipment are securely stored.
  • Maintain current equipment, manuals.
  • Assist supporting departments on the selection of new, replacement of test and measurement devices.
  • Determine, develop and maintain spare calibrated instrumentation to support critical processes in the event of suspect performance.
  • Maintain Calibration files for ease of retrieving metrology documentation for audits and customer requests.
  • Assist in review and approval of, Laboratory Work Orders, Out of Tolerance Evaluations, Equipment registration documentation.
  • Provide technical assistance when require for Deviation, CAPA, root cause analysis to complete investigations.
  • Act on behalf of Metrology Department Supervisor in their absence.

REQUIREMENTS

  • Minimum of a 2-year Associate's Degree in Electronics, or Science related field or equivalent practical experience.
  • Must have five year of experience in a highly technical environment.
  • Preferred formal Military PMEL Training
  • Proficient in Statistical Analysis, Six-Sigma
  • Proficient interpersonal / communication, and technical writing skills.
  • Proficient Windows application software skills.
Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

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