- 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
- College diploma (entry level)
- Maintain current equipment
- New Equipment Procurement and Qualification
- Other duties
Maintain current equipment
- 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
New Equipment Procurement and Qualification
- 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
Must Have Skills
- 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.
Type of companies that hire
- Cosmetic Industry
- Contract Labs
- Cannabis Industry
- Laboratory Equipment Service labs
- Equipment suppliers
at least one year of chemist/ analyst experience
Calibration Technician/ Chemist –> Specialist –> Metrology Supervisor/ Manager –> Director
–> consider working for the analytical equipment manufacturers and suppliers, in the R&D department or as field service engineers/technicians (highly recommended for B.Eng.)
Your other options are same as QC Chemist. Please refer to QC Chemist Career Growth.
- QMS Standard Operating Procedure (SOP) Template (FDA) –> this document states how equipment are maintained in FDA’s lab. This will give you an idea of maintaining equipment as similar steps are taken by pharma industry as well.
- Guideline: Validation on Qualification of Systems, Utilities and Equipment (WHO, June, 2016)