Calibration Technician

4 weeks ago

Cincinnati, United States Meridian Bioscience Full time

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary

Responsible for managing the timely execution and review of maintenance and calibration activities of production equipment. Use of NIST standards and calibration equipment to evaluate and document the performance of equipment used in the production of FDA regulated medical diagnostic devices. Responsible for oversite and coordination of vendors during 3rd party calibration events. A heavy emphasis on documentation in compliance with current Quality System Regulations (QSR) and ISO standards is required. Assists other employees in the use and management of equipment in a validated asset management database and environmental monitoring system.

Key Duties

Major Duties and Responsibilities:

Support the Quality Policy, as well as overall ISO/QSR requirements. Maintain complete, accurate, real-time documentation of all activities as required for compliance to ISO/QSR standards. Review Calibration department scheduled work orders to ensure compliance as well as scheduled work orders completed by other departments for completeness of work. Manage the filing system for paper equipment records to ensure they are maintained in an organized manner and stored to protect the integrity of the documentation. Ensure existing equipment systems are maintained and operating within calibration, including adjustment of the equipment as needed and assist with generation of unplanned work to document out of tolerance events. Manage receipt of new equipment including physical receipt and asset tagging of the equipment, electronic data entry of equipment specifications and maintenance/calibration activities, and determination of additional activities required prior to release for use. Assist with troubleshooting equipment issues. Identify and segregate out of service equipment from active equipment. Contact external providers to send standards for calibration and arrange onsite service visits. Escort technician while on site as needed. Manage the equipment/room alerts received during work hours from the environmental monitoring system. This includes contacting the equipment/room owners to verify the cause, monitoring parameters for recovery, and ensuring alerts are promptly addressed to protect the integrity of the stored material/product. On-call duties will be required (on a rotational basis) due to environmental monitoring activities. This includes promptly addressing alerts received during off-hours, contacting the equipment owner as needed, monitoring parameters for recovery, and coming onsite to relocate materials as needed. Assist with deviations and corrective/preventive actions as they relate to the Calibration Department. Assist with writing, revising, and maintaining procedures used by the Calibration Department. Assist other departments with the use of the equipment asset management database and environmental monitoring system. Train other employees as needed.

Other duties as assigned:

Ability to lift 25 pounds routinely through the course of the workday. Ability to stand for long periods of time, stoop, reach, push and pull carts/equipment throughout the course of the work shift. Ability to walk up and down flights of stairs throughout the workday in a multi-location facility. Ability to work on PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday. Must be able to wear personal protective equipment (safety glasses, latex or nitrile gloves, hairnets, shoe coverings), as needed. Must be able to adhere to applicable bio-safety practices when working in restricted areas. Must be able to drive from site to site within Meridian campus to inspect equipment, deliver, and/or perform equipment calibration. Ability to perform visual inspections. Ability to concentrate, problem solve, analyze, and interpret data throughout the course of the work shift.

Qualifications

Minimum Education or Equivalent Experience Required/Preferred:

Associate degree preferred or High School diploma or GED 2 years of related industry experience required.

Competencies Required or preferred:

Must possess a working knowledge of calibration methods, metric system, and mathematical/writing aptitudes. Ability to read, understand, and follow all company SOPs and guidelines. Must maintain accurate and precise records. Must have strong analyzing, problem solving, and troubleshooting skills. Must have strong oral and written communication skills along with the ability to interact well with all levels of the organization. Ability to work collaboratively in a team setting with peers and colleagues in a cross functional setting. Must be a self-starter, able to prioritize and handle multiple tasks, meet strict deadlines, and perform under pressure in a fast-paced work environment. Must be able to perform basic job requirements independently with minimal supervision. Must have basic computer proficiency with Microsoft Office products (Word/Excel). Must possess an understanding of general laboratory equipment operation. Thorough understanding of Quality System Regulations of an FDA regulated facility. Ability to maintain regular attendance and punctuality requirements. Ability to have flexibility to work hours outside the normal workday (start early, stay late, or weekends) to support department activities and coordinate with production schedules. Ability to participate in on-call rotation to provide off-hours environmental monitoring and respond to alarm notifications (on a rotational basis).

*We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing. (USA Only)*

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