Validation and Calibration Specialist
About The Position
Element Concord is currently hiring for a Validation and Calibration Specialist for our growing team in Concord CA. The responsiibility of the Validation and Calibration Specialist is to perform validation and calibration activities as required per compliance with SOPs, Quality Manual, ISO 17025:2017, and GMP requirements at Element Concord. This role primarily involves performing temperature mapping qualifications (IQ/OQ/PQ) independently, managing vendor equipment services (calibration, PMs, validations, etc), writing quality events, and preparing technical reports. Responsible for monitoring and verifying operation, calibration, and service condition of laboratory equipment. May perform calibrations and instrument validations based on experience and qualifications.
Requirements
- B.S. in science desired with typically 2-5 years of validation and qualification experience in GMP industry. Metrology certificate preferred.
- Previous experience with temperature mapping, thermocouple prep, handling, and calibration.
- Technical writing, review, and analytical skills in addition to strong verbal communication and presentation skills.
Nice To Haves
- Experience with Ellab and Veriteq Temperature monitoring systems a plus.
Responsibilities
- Perform temperature mapping qualifications for freezers, refrigerators, incubators, and autoclaves.
- Coordinate or perform validation and calibration of equipment
- Prepare validation protocols and procedures
- Perform quality event investigations for out of tolerance or nonconforming equipment
- Operate as point of contact for equipment vendors
- Other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1-10 employees
