Lead Calibrations Technical Specialist job in Edison
|Employer:|| MTF Biologics|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
Edison, NJ 08837, USA (Show on map)
The Lead Technical Specialist, Calibrations will also provide technical assistance regarding technical reports and non-conformance investigations. This position will also compile Blue Mountain Calibration Manager reports including statistical and presentation data for management reports regarding all MTF sites. This position may also require scheduled and non-scheduled, non-standard work hours in addition to travel to other MTF sites in the United States.
1. Schedules and documents equipment calibration for clean room and laboratory equipment for primary and secondary calibration events in order to ensure compliance with all internal and external Quality requirements.
2. Inputs data into the Blue Mountain Calibration Manager Database for completed calibration events for Edison, Jessup, Olyphant, and other facilities, as required, to maintain accuracy of the current corporate equipment calibration database.
3. Generates requested reports needed for inventory, and/or internal and external audits, for all MTF sites.
4. Maintains and audits master file for completed calibration documentation for MTF equipment. Ensure these files are current, accurate, and in good order for audits as needed to ensure compliance with internal and external Quality requirements.
5. Assist in completion of calibration-related non-conformance (NCR) and Corrective and Preventive Action (CAPA) reports.
6. Maintains applicable Standard Operating Procedures related to calibration practices and calibration management database activities.
7. Assist with budget tracking of departmental expenses and expenses associated with other business units in regards to shutdown calibration events.
8. Prepares purchase orders and tracks budgets relating to calibration activities. Maintains equipment manuals and reports. Assist with special projects and perform additional duties as assigned. (exempt)(non-exempt)
Education: Bachelor's Degree in science field
Years of Experience: 5 - 7 years
Other: 5 years’ experience in a regulated manufacturing facility. 1+ years calibration management experience.
Specific Licenses and/or Certifications: N/A
Specialized Knowledge, Technical Skills, and Abilities:
Must be self-directed, service and goal oriented, ethical, exhibiting strong communications, supportive to upper management. 2. Excellent written and verbal communications skills 3. Excellent computer skills required 4. Working knowledge of cGLP, cGMP required within regulatory requirements. 5. Proficiency in Microsoft Word, Excel, database skills. 6. Ability to schedule and coordinate with internal and external clients and vendors. 7. Excellent written and verbal communication skills. 8. Ability to plan, coordinate and track shipments. 9. Audit related experience required. 10. Knowledge of Blue Mountain preferred or other calibration/maintenance management software required. 11. Ability to work non-scheduled hours and travel as necessary
Education: Bachelor's Degree in Engineering, Instrumentation/Calibration science – related field
Years of Experience: 5- 9 years
Other: 1. 5 + years Calibration experience preferred. GLP experience. 2. 5+ years’ experience in calibration (preferred) or maintenance coordination, equipment event scheduling. 3. Supervisory skills helpful. 4. Knowledge of AmegaView, REES and/or Trane Environmental Monitoring Systems or other Building automation/monitoring systems helpful. 5. Experience with building automation/monitoring systems helpful. 6. Knowledge of Cleanrooms and/or sterile technique helpful.
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