Calibration Metrology Spec

Job Summary

This position is responsible for supporting the site calibration program. Perform calibration activities for production and laboratory equipment throughout equipment life cycle to internal SOPs and external standards and guidelines. Document results and prepare technical reports for the calibration and assist in managing any deviation from expected results. 

This position will work first shift.

Job Details/Responsibilities

1.    In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 
2.    Maintain calibration schedule and assist with the PM of the equipment with vendors.
3.    Assist in maintaining vendor calibration records and other associated documents.
4.    Perform calibration activities to support IQ / OQ / PQ of new/modified and relocation activities.
5.    Work collaboratively with Engineering, Production, Quality Assurance, and IT departments to ensure strict compliance with GMP guidelines, specifically to ensure that equipment is maintained in GMP compliance
6.    Provide input in the selection of measuring/test equipment.
7.    Assign identification numbers to new measuring/test equipment.
8.    Assist in review of existing calibration procedures to ensure compliance with requirements (internal & vendor’s) and accuracy.
9.    Troubleshoot, test, repair and optimize instruments, equipment, and control systems.
10.    Work collaboratively with vendors to request services as applicable for resolution of issues.
11.    Write Standard Operating Procedures and Test methods for equipment.
12.    Manage change controls for equipment documents.
13.    Appropriately document service on instruments including calibration incidents.
14.    Identify and communicate to management out of tolerance equipment and drive to resolution.
15.    Escort vendors on-site to perform maintenance activities on instruments on contract.
16.    Provide and oversee training for associates performing any aspect of internal calibrations and/or processing external calibrations.
17.    Participate actively in metrics calibration activities. 
18.    Calibration subject matter expert, requiring participation in internal and external audit activities
19.    Perform other related duties as assigned.
 

Working Conditions/Physical Requirements

The position exists in a production environment with minimal exposure to automated equipment. May require gowning procedures for controlled environment. May require the use of eye protection, hand protection, and depending on the noise level, may require hearing protection. 
Visual acuity in compliance with site specific Visual Acuity Program. Majority of workday is spent standing and walking with considerable reaching, pulling, stooping, etc. Typically include frequent lifting of up to 50 lbs. and occasional lifting, with assistance, up to 100lbs. This position is not eligible to work remotely. This may change based on job responsibilities, project/business needs and/or Associate job performance.  In all cases Associates may need to have on-site presence for designated meetings and compliance related activities.
 

Qualifications/ Background Experiences

Requires a minimum of an associate degree in engineering, life sciences, or related degree and a minimum of five years of experience in related field. Bachelor’s Degree preferred.  Intermediate computer software skills, i.e. Microsoft Office. Prefer certification as a CQA, CQE, or CQM, and member of the ASQ.