Analyst, Quality Control

RenaudExec & Associates Inc.; Canada; On-site; CAD 60,000 - 80,000; Full time

Job summary

A Canadian pharmaceutical company is seeking a Quality Control Analyst to join their laboratory team. This role requires expertise in wet chemistry techniques, HPLC, and UV testing, along with a strong background in GMP and GLP compliance. Candidates should hold a Master's or Bachelor's degree in Chemistry and possess a minimum of three years of relevant experience. The analyst will ensure product quality through rigorous testing and documentation, while also participating in method development and validation processes.

Qualifications

• Minimum of 3 years Quality Control experience in the Pharmaceutical industry.
• Good knowledge of GMP, GLP, analytical techniques, and method validation.
• Excellent oral and written communication skills in English and French.

Responsibilities

• Perform tests for Certification of Analysis of Raw Material, Finished Products, and Stability Samples.
• Document and report results in accordance with GMP and GLP.
• Participate in method validation and development.

Skills

Analytical techniques

Problem solving skills

Communication skills

Organizational skills

Education

Master or Bachelor in Science, major in Chemistry

Tools

HPLC

UV

GC

LC-MS

Job description

Our client, a Canadian pharmaceutical company with fully integrated infrastructures for R&D, manufacturing, distribution, and marketing, is looking for a Quality control analyst for their laboratory. Their vast product line includes innovative and generic products as well as over-the -counter products. Their products are also exported to several countries around the world.The position relies heavily on comprehensive wet chemistry techniques, dissolution, HPLC and UV testing on raw materials, in-process, final products and stability samples per established SOPs and pharmacopoeia product specifications.As a QC analyst you will be:

• Performing tests for Certification of Analysis of Raw Material, Finished Products and Stability Samples
• Documenting and reporting results in accordance with GMP and GLP
• Participate in method validation protocoland reports in a timely manner with accuracy and precision in compliance with laboratory SOPs, product specifications, and regulatory guidelines
• Participate in method development and method validation/verification for API and finished products
• Participate in the resolution of issues with respect to laboratory analysis and laboratory instrumentation
• Performing all work in accordance with all established regulatory, compliance and safety requirements
• Conducting investigation of unexpected issues in developmental and regular products as directed and provides solutions to resolve the findings
• Revising and updating existing methods when required
• Participating in the development and/or providing recommendations for department SOPs and procedures

Education and competencies:

• Education: Master or Bachelor in Science, major in Chemistry
• Experience: Minimum of 3 years Quality Control experience in the Pharmaceutical industry
• Specialized Training: Good knowledge and understanding of GMP, GLP, analytical techniques and method validation.
• Sound theoretical and technical knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, LC-MS, AA, TOC, etc.
• Sound understanding of current GMP, ICH and FDA requirements
• Excellent organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required
• Excellent oral and written communication skills in English and French
• Willing to work in a team-based environment