Senior QC Laboratory Analyst

at  Shields Pharma Inc

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.
Shields Pharma Inc. is an equal opportunity employer committed to diversity and inclusion for everyone. We are continuously looking for smart-minded, skilled, qualified, experienced, independent, reliable, and detail-oriented candidates to join our successful team.
Our people are at the heart of everything we do.

You can count on;

• Safety as our first core value,
• Integrity,
• Accountability, and
• Continuous Training and skill development

Position Title: Senior Quality Control Analyst
Reports To: Chief Scientific Officer and Laboratory Manager

JOB DESCRIPTION:

The Senior Quality Control Analyst supports both R&D and Quality Control analytical activities at Shields Pharma laboratory.
The Senior Quality Control Analyst is responsible for conducting method development and validation, method transfer, assay and impurity analysis by utilizing HPLC, LC/MS, UPLC, GC-Headspace, GC/MS, ICP-MS, and Dissolution instrumentation according to the schedule established by following the procedures and adhering to Good Manufacturing Practices (GMP), GXP, and good laboratory practices.
The successful candidate will be working in a very fast paced environment, performing both R&D and QC analysis of assigned raw materials, in-process, and final products as per established methods, current pharmacopoeias (e.g. USP, BP, EP, etc.), and the client’s methods and specifications within standard time-lines, and under minimal guidance/supervision.
This position relies heavily on comprehensive wet chemistry and strong chromatographic skills and competencies.

Duties shall include but are not limited to the following:

• Perform all works in accordance with all established company policies, protocols and procedures, and governing regulatory, GMP compliance, and safety guidelines.
• Perform assay and impurities method development, method validation, method transfer, cleaning validation, and stability testing.
• Maintain accurate documentation including lab reports, records of procedures, results, and data analysis in accordance with Good Documentation Practices (GDP) guidelines
• Maintain professional relationship with Internal/External Customers
• Provide scientific advice and training to junior analysts on laboratory instrumentation and methods.
• Perform peer review of analytical reports and data when requested.
• Document and report results in accordance with GMP and GLP
• Conduct Laboratory Investigation (OOS, OOT, Deviation, etc.).
• Provide technical support to other analysts when required
• Collaborate with cross-functional teams to support R&D projects.
• Ensure all general lab supplies (chemicals/non-chemicals) are available at all time.
• Ensure the laboratory is clean in an orderly manner at all time.
• Participate in client audits and health authorities’ regulatory inspection (i.e., Health Canada and FDA GMP, inspections, and Health Canada OCS audits).
• Ensure all analysts documentation including lab reports, records of procedures, results, and data analysis are accurate and in accordance with Good Documentation Practices (GDP) guidelines.
• Provide oversight of external vendors who are delegated responsibilities when requested.
• Participate in client audits and health authorities’ regulatory inspection (i.e., Health Canada and FDA GMP, inspections, and Health Canada OCS audits).
• Ensure all generated documentation including lab reports, records of procedures, results, and data analysis are accurate and correct.

Job Requirements: (Work Status, Qualification, Knowledge, and Experience)

• Must possess Permanent Canadian residency with work permit and/or Canadian citizenship.
• Must be living in Canada, preferably in Toronto area
• Minimum M.Sc. (min. 3 yrs. industry experience), or B.Sc. (min. 5 yrs. industry experience), preferably in Chemistry, Pharmaceutical, Analytical Chemistry or similar applied scientific disciplines.
• Must have worked minimum of 5 years (depending on the qualification) in pharmaceutical laboratory discipline.
• 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.
• Must demonstrate expertise in analytical; method development, method validation, investigational studies, method transfer, stability studies, and preparation and execution of protocols, etc.
• Should be well versed in understanding of USP, BP, EP, and JP, methods and specifications.
• Must have in-depth knowledge and competency in cGMP/GMP (Good Manufacturing Practices), GDP (Good Documentation Practices), GXP, FDA CFR 211, ICH, and ALCOLA+ regulation and quality system guidelines.
• Should be able to conduct laboratory investigation and other quality attributes (e.g. SOP development, Change Control, Deviation, Root Cause investigation and analysis, CAPA, TAR, etc.)
• Proficiency to MS office (Excel, Word, PowerPoint) is a must
• Track record of multi-tasking, being detail-oriented, trouble-shooting/problem solving abilities, working in a fast-paced environment with minimal instruction on routine work and moderate instruction on new assignments.
• Be punctual, team player, fast learner, and have strong Interpersonal and communication skills,

• Perform all works in accordance with all established company policies, protocols and procedures, and governing regulatory, GMP compliance, and safety guidelines.
• Perform assay and impurities method development, method validation, method transfer, cleaning validation, and stability testing.
• Maintain accurate documentation including lab reports, records of procedures, results, and data analysis in accordance with Good Documentation Practices (GDP) guidelines
• Maintain professional relationship with Internal/External Customers
• Provide scientific advice and training to junior analysts on laboratory instrumentation and methods.
• Perform peer review of analytical reports and data when requested.
• Document and report results in accordance with GMP and GLP
• Conduct Laboratory Investigation (OOS, OOT, Deviation, etc.).
• Provide technical support to other analysts when required
• Collaborate with cross-functional teams to support R&D projects.
• Ensure all general lab supplies (chemicals/non-chemicals) are available at all time.
• Ensure the laboratory is clean in an orderly manner at all time.
• Participate in client audits and health authorities’ regulatory inspection (i.e., Health Canada and FDA GMP, inspections, and Health Canada OCS audits).
• Ensure all analysts documentation including lab reports, records of procedures, results, and data analysis are accurate and in accordance with Good Documentation Practices (GDP) guidelines.
• Provide oversight of external vendors who are delegated responsibilities when requested.
• Participate in client audits and health authorities’ regulatory inspection (i.e., Health Canada and FDA GMP, inspections, and Health Canada OCS audits).
• Ensure all generated documentation including lab reports, records of procedures, results, and data analysis are accurate and correct