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Calibration/Metrology Specialist in South Plainfield, NJ at Integrated Resources, Inc

Date Posted: 3/4/2019

Job Snapshot

Job Description

Metrology Specialist reports to and takes direction from the Metrology Manager. The Metrology specialist will be responsible for supporting the development of the metrology program and department to meet the growing needs of our current facility, as well as future facilities.
  • Oversee and support all approved vendor activities for Calibration, Certification, and Preventative Maintenance (PM) (instrumentation, utilities, EMS, and equipment) for all cGMP areas as well as non-cGMP areas including Manufacturing, QC, and R&D.
  • Collaborate with all departmental end users to coordinate schedules, ensuring all activities are conducted by due dates and assuring compliance with appropriate SOPs.
  • Support the review and upload to CMMS/CCMS of calibration, PM, and certification documents as a Subject Matter Expert (SME) in order to identify and initiate Out Of Tolerance (OOT) investigations as needed.
  • Support the OOT investigation process with all departmental end users and collaborate with QA to ensure all investigations and / or CAPA procedures are met.
  • Support all SOPs relating to Calibration, Certification, and PM for all equipment and instruments. This includes revisions to current SOPs based on changes in industry guidelines and regulations, as well as support the generation of new SOPs as needed for new equipment (Continuous improvement).
  • Support development and execute Calibrations and specified PM tasks as the capabilities are established in-house.
Minimum of 3 years Pharmaceutical or Regulated industry experience in Calibration / Metrology
ISA Level I certification preferred (or equivalent training and/or certifications)
Other special projects and/or duties may be assigned by Management.
Work as a team member to establish and support calibration / metrology program for tracking, scheduling, and management. Take a lead role in developing and uploading into a MMS, as well as maintaining and managing the MMS ongoing.
Establish good working relationships with other departments.
Strategically work with Metrology and Facilities management. Oversee vendors work. No direct company reports at this time.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
  • Ability to write routine reports and/or correspondence.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
The employee may frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
Additionally, in the performance of the duties of this job, the employee may be required to travel, drive a motor vehicle, and communicate using telephone and e-mail.
The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations will be made to enable individuals to perform these functions.