Job purpose
The main responsibility of this position is to maintain GMP compliance of all instruments and equipment assigned to the Metrology group.
Duties and responsibilities
- Calibration / verification of instruments and equipment
- Review and revise calibration / verification procedures to remain compliant
- Work with internal customers to assist in the introduction of new equipment. This will include working with vendors as well as groups purchasing equipment.
- Creating test methods for verification of new equipment
- Interpretation of test results and creating a plan if additional testing is required
- Coordinating with third party contractors for repair and calibration appointments
- Complete all documentation following GMP guidelines and company SOPs
- Complete training as required by training matrix
- Document all steps performed in case of an NCI
- Complete requirements as related to Corrective and Preventive Actions (CAPA’s)
- Initiate Change Controls providing steps required and including other stakeholders
- Participate in Internal, Customer and Regulatory Audits.
- Order supplies required by group
Qualifications
- B. Sc. Chemistry or equivalent
- 3-5 years of laboratory experience
- Understanding of MSDS for safe handling of chemicals used in testing
- Ability to communicate with other team members on group tasks
- Ability to diagnose equipment issue and decide if the issue can be resolved internally or requires external service. All steps will be documented and procedures must be followed.
- Working knowledge of Empower software
- Experience with Waters and Agilent HPLCs
- Experience with Agilent GCs
- Multitasking ability including changing priorities as required
- Document report writing
- GMP guidelines
Working conditions
- Daily tasks are performed in a laboratory environment. While performing tasks there will be exposure to chemicals and their associated odours used in product manufacturing and testing.
- There is occasional exposure to higher than normal noise levels.
- Overtime is required that may include coming in early, working late or weekends.
- Prior notification of overtime may not be possible and will be distributed to all group members.
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