Calibration Specialist - Eurofins BioPharma Product Testing Toronto, Inc
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- Mississauga, ON
- Permanent
- Temps-plein
- conduct calibration on the required equipment, in both Chemistry and Microbiology labs, and setting timelines and work schedule
- Trouble shoot any equipment prior to coordinating its repair with the external vendors
- Perform data integrity analysis of software for the existing and new laboratory equipment
- Work closely with Metrology Manager and the QA Director or Designate on creating, updating and reviewing site QA controlled documents related to calibration/qualification/maintenance activities
- Leading and initiating the Change Management process for any new equipment and lead the commissioning process.
- Establish and maintain professional business relationships with clients and peers.
- Prepare, write and execute qualification (IQ/OQ/PQ) protocols for instrumentation
- Maintain the VMP and equipment lists by performing the annual review for the VMP
- Play an active role in internal and external audits and prepare audit responses
- Train employees on laboratory equipment and techniques and prepare training records
- Conduct temperature/humidity excursion investigations and prepare deviation reports
- Respond to the monitoring system alarms events. This might include the need to drive into the building during off-shift hours to respond and react to any system monitoring alarms.
- Follow safety procedures within the labs and follow company policies
- Troubleshoot and respond quickly when problems arise
- Any other duties as requested by the Metrology Manager and the QA Director
- Bachelor's Degree in Science/Engineering
- 2+ year experience being a Calibration Specialist
- 3+ experience working in a GMP environment
- Solid experience in pharmaceutical testing operations
- Strong knowledge with cGMP testing & ICH guidelines and release procedures.
- Must speak and write English fluently
- Must possess excellent communication skills, both written and verbal, in order to maintain communication with internal and external clients
- Excellent organizational & inter-personal skills
- Ability to work independently, while supporting a collaborative, team-based department
- Must be proactive, self-disciplined, and able to demonstrate a high level of productivity with a goal-oriented approach
- Ability to effectively work under pressure.
- Exceptional technical skill related to laboratory instrumentation
- Ability to adapt to new technologies and software.