Metrology Specialist

2 months ago

Markham, Canada Shields Pharma Inc. Full time

**About Shields Pharma Inc.**

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario.

We offer Laboratory R&D and QC testing services as well as production and formulation of certain psychedelic therapeutics for treatment of certain mental health disorders such as anxiety, depression, obsessive-compulsive disorder, PTSD, and problematic substance.

Our people are at the heart of everything we do. You can count on;
- Safety as it is our first core value,
- Integrity,
- Accountability, and
- Continuous Training and skill development

We are currently looking for the following individuals to join our growing team

**Position Title**: Metrology Specialist (Full-time)

**Reports To**: Head of Operation & Laboratory Manager

This is a technical position involving qualification, calibration, preventative maintenance, and repairs of the of laboratory and facility instrumentation and equipment in accordance to Shields Pharma Inc. applicable SOPs and policies, GXP, ICH, GAMP, FDA CFR 211, ALCOLA+, and other regulatory guidelines and requirements.

**Duties and responsibilities include, but are not limited, to the following**:

- Performing Shields Pharma instrument and equipment IQ, OQ, PQ qualification and Calibration activities.
- Performing preventive maintenance and troubleshooting of laboratory and facility equipment and instrumentation, and control systems.
- Following company’s written procedures
- Preparing technical SOPs.
- Executing Repairs and accurately documenting repair activities.
- Assessing instrument failures/breakdowns, systematically identifying problems, and restoring to operation
- Review and update calibration procedures based on field experience.
- Supporting, overseeing, and supervising contractors/services providers performing tasks within the company and ensuring the external contractor/s are adhering to the company safety requirements and cGMP standards.
- Identifying opportunities for improving Shields Pharma metrology programs.
- Preparing accurate and comprehensive qualification and calibration protocols and reports in accordance to the company policies, procedures, GDP, and cGMP.
- Completing calibration, PM, and repair documentation accurately and comprehensively including work orders and logbooks in accordance to Shields Pharma policies and procedures, ALCOLA+, FDA CFR 211, and others.
- Ensure equipment/instrument qualifications, calibrations, repairs and maintenance documentations are up-to-date and archived.
- Create and/or revise calibration and operation procedure/s.
- Support Quality Assurance investigations of instrument failures/breakdowns.
- Perform any other tasks/duties as assigned by departmental management.

**Job Requirements **(Work Status, Qualification, Knowledge, Skills, and Experience)
- Must possess Permanent Canadian residency with work permit and/or Canadian citizenship.
- Must be living in Canada, preferably in Toronto area
- **Minimum** Science degree in Chemistry, Analytical Chemistry, Mechanical/electronic Engineering, or similar applied scientific disciplines.
- **Minimum of 3 - 4 years** of direct and hands-on experience working experience in equipment and instrumentation, qualification, calibration, PM, trouble shooting, and repairs in pharmaceutical laboratory and production environment.
- Familiar with a variety of hand tools, electric meters, calibration standards to perform essential day-to-day duties.
- Experience working in a Pharmaceutical or similar regulated industry preferred.
- Must be skillful in authoring and executing calibrations, preventative maintenance, repair work where applicable, and other service-related work and documentation.
- **Must **demonstrate solid technical knowledge and extensive expertise on operation, Qualification, trouble-shooting, and maintenance of sophisticated laboratory instrumentation and equipment including, LC/MS, UPLC, HPLC, GC-Headspace, GC/MS, ICP-MS, and dissolution.
- Basic understanding of pneumatic, electrical, and mechanical control systems such as PID Controllers, smart devices, programmers/communicators, and multimeters.
- Sound knowledge of Pharmaceutical regulation and guidelines including cGMP, ALCOLA+, FDA CFR 211, GAMP, and NIST as applied to equipment and instrument qualification, calibration and Preventative Maintenance.
- Be able to troubleshoot and repair complex systems and instruments
- Must be focused on problem at hand in a systematic manner and troubleshoot complex systems and instruments.
- Should be able to isolate problem, identify root cause/s, and resolve the issue in a systematic manner.
- Working knowledge of OSHA safe work practices.
- Must be comfortable working with Microsoft Office Applications, including Microsoft Word, and Excel
- Demonstrate strong people and interpersonal skills including being a team player, problem solver, active listener, easy to work with, etc.
- Should demonstrate multi-tasking abilities working in a fast pace

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