Calibration Chemist

Calibration Chemist
Instrumentation Chemist (this title could also apply to QC chemists working with analytical instruments so make sure to read the job description)
Calibration Specialist
Instrumentation Specialist

Perform scheduled calibration test and/or preventative maintenance (PM) on all analytical equipment in the lab as per the company standard operating procedures (SOP) and complete within the allocated time
Document and report results in accordance with the relevant SOP’s and good manufacturing practices (GMP)
Once the calibration/ PM is completed and reviewed by the QA and approved, release the equipment for use
If the calibration/ PM fails, initiate appropriate investigation paper work.
Ensure all the equipment have the calibration/ PM labels and are within the calibration/ PM dates
If the equipment are due for calibration/ PM, put the appropriate ‘out of service’ sign up
Contact external contractors and schedule a visit for calibrations, repair and maintenance of equipment as needed

Budget for any needed new equipment
Procurement of new equipment for the lab by researching and identifying new equipment requirements and the supplier to purchase it from with the optimal price quote and planning.
Create a unique equipment ID for the new equipment. The equipment ID should contain all the equipment related information.
Write the Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) protocols for the new equipment.
Perform IQ, OQ and PQ as per the protocols
Write IQ, OQ and PQ results summary report
Write Standard Operating Procedure (SOP) for the new equipment
Train chemist/analyst on how to use the new equipment
Create user accounts for analyst/chemist
Add the equipment to the calibration and PM schedule

Maintain calibration and PM schedules, equipment inventory and calibration standards.
Decommission equipment that are no longer in use following the company practice and the appropriate SOP
Maintain calibration/ validation data, hard copy and soft copy. If using the LIMS system, scan and attach the calibration paper work to LIMS.
Train analyst/ chemist on the use of analytical instruments as needed
Perform any needed analytical equipment troubleshooting in a timely manner as to not have the system down for longer period of time and delaying the lab testing schedule

Some experience with analytical instruments
Experience working in the GMP lab environment
Interest in working with instruments and instrument related software
Excellent computer skills, including creating user accounts.
Strong communication, interpersonal and organizational skills
Knowledge of
- Good Manufacturing Practices (GMP), GDP (Good Documentation Practices as per GMP), WHIMS, Standard Operating Procedures (SOPs), Test Methods
- USP, FDA, Health Canada
Good documentation practices
Work well under pressure and in a ‘fast paced and minimal tolerance for mistakes’ environment
Able to do the same testing over and over again
Detail oriented and ability to follow written procedures without any deviation
Honest and transparent
Able to take responsibility for your own action
Work well individually and as part of a team
Professional, fast learner and takes initiative.
Able to work in a highly regulated environment and follow company Standard Operating Procedures (SOPs), regulatory guidelines and safety standards.