North York, Ontario
Compliance manager – Metrology
12 months contract/ Toronto
Be able to co-ordinate work with other metrologist and other maintenance personnel by assuring documentation is in correct state to commence Metrology activities. Manage Calibration Workstream, Functional Component Criticality Assessments from a metrology point of view, and other day to day activities. Maintain the Metrology/Calibration Program within the Facilities Management Division at a level that meets safety, regulatory compliance and/or applicable government guidelines and codes thus ensuring there is no in project schedule. Assist in the development /implementation of key documents (Project Plans, SOPs, and Standards) by providing technical recommendations (risk/benefit).
• (40%) Develops and implements certification program for site
a. Establish frequency and tolerances to be applied for certification on GxP critical devices
b. Ensure compliance with cGMP guidelines and regulations with respect to certification programs
c. Ensures equipment is maintained in certified status. Any changes to equipment are reviewed and evaluated to ascertain whether additional studies, repairs and/or re-certifications are required
d. Ensure industry best practices are reflected in departments SOP’s
• (20 %) Writes and reviews SOPs, certification protocols and reports as required
a. Contributes to the writing of corporate policies for Metrology.
b. Presents and justifies changes to site policies and procedures
c. Write and/or review standard operating procedures for equipment and procedures throughout the company with respect to metrology
d. Ensure that all departmental processes are covered by SOP’s and are maintained as current
e. Provides expert review of OQ (Operating Qualifications) protocols and reports as required.
• (20 %) Maintains the competency of department
a. Ensures department has skills and competence required to carry out certifications.
b. Trains technical and users on how to apply Metrology principles
c. Maintains self up to date on industry best practices
• (20 %) Provides expert assistance in selection of equipment/instrument or troubleshooting
a. Render expert assistance in troubleshooting certification and/or production failures linked to critical devices
b. Review equipment specification documents to ensure calibration constraints taken into consideration prior to purchase
c. Trains staff in root cause analysis as it pertains to critical devices
• A minimum of 5+ years experience in a metrology, calibration, and/or quality function in a sophisticated manufacturing environment.
• Proven record as a both a Manager and Business Leader
• A Bachelor of Science Degree or College Diploma with ASQ certification or ability to complete ASQ
Certification within the first year of service.
• Experience working with Microprocessor controlled equipment, multi-point Temperature Recorders, PLC’s and PID’s, temperature & pressure devices and calibration instruments and standards.
• In depth knowledge of metrology, calibration, testing and certification of equipment and instruments.
• Statistical Analysis: Ability to conduct trend analysis, interpretations of data so as to show meaningful results of study.
• Scientific report writing techniques to include: writing SOP’s, protocols, monthly reports etc.
• Excellent written and verbal communication skills
• Interpersonal skills and ability to function as part of a team while motivating technical staff to achieve results.
• Ability to negotiate with users to best define process and instrument tolerances.
• Problem solving skills with ability to identify root cause of certification failures or trends.
• Experience working with Procal a plus
• Experience working with Autoclaves, Ovens and Fermentors.
• Training in cGMP guidelines