Job Description
Job Description Job Description Job Title: Calibration Technician III
Location: Morrisville, NC 27560
Duration: 8 Months
Pay Rate: $34.91/hr.
Calibration Execution:
Location: Morrisville, NC 27560
Duration: 8 Months
Pay Rate: $34.91/hr.
- The Calibration Technician manages laboratory equipment calibrations, maintenance, and repairs, ensuring compliance with all GxP regulations.
- This role is responsible for the quality review of documentation and the initiation of deviation investigations related to metrology.
- Individual works under the supervision and direction of more senior level roles and uses existing procedures to solve routine or standard problems
Calibration Execution:
- Independently performs maintenance, calibration, and repairs on active equipment, including loop calibrations.
- Reviews and approves equipment calibration and maintenance documentation performed by external vendors with a detailed eye for good documentation practices.
- Ensures all calibration activities comply with relevant industry regulations (e.g., USP, NIST, FDA, GLP, GMP).
- Adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents.
- Maintain training compliance in the Quality Management System.
- Initiates, writes, and assists with investigations related to instrument calibration failures or other instrument related issues.
- Primary responsibility for the initiation, writing, and support of investigations (Deviations/CAPAs) related to instrument calibration failures or other instrument-related issues.
- Oversees and manages onsite vendors to ensure all training and compliance requirements are met for maintenance, calibration, and repairs on laboratory equipment.
- Responsible for the technical review and approval of all equipment calibration and maintenance documentation performed by external parties with a detailed eye for good documentation practices.
- Induction of new equipment including development of calibration requirements and schedules in coordination with equipment owners and planner / scheduler.
- Research the operating specifications of new equipment, obtain suitable standards, and establish the calibration acceptance criteria.
- Maintains and/or generates SOPs and controlled documents pertaining to the calibration program.
- Thoroughly documents all activities and reviews all data to ensure completeness and accuracy within the CMMS.
- Interfaces with multi-disciplinary teams regarding laboratory equipment including, lab staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT.
- High School Diploma and 6 years of metrology experience OR Bachelor's Degree and 2 years of metrology experience in the Pharma/Biotech industry.
- Experience investigating and completing CAPAs and deviations in a GxP environment.
- Strong understanding of calibration methodology, tolerances, and FDA regulations.
About TalentBurst, Inc.