Title:  Analyst, Calibration

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 (such as GC, HPLC/UPLC, balance, pipette, UV-VIS spectrophotometer, IR spectrophotometer, thermometer, ovens, viscometer, invitro diffusion system, Karl Fisher titrator, pH/conductivity meter and dissolution system)
• 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 a non-conformance investigation
• 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

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• B. Sc. Chemistry or equivalent
• 3-5 years of laboratory experience
• Understanding of SDS 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/UPLCs
• 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 

Physical requirements

NA

Direct reports

NA