Analyst, Quality Control

RenaudExec; Montreal; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in Montreal is seeking a Quality Control Analyst to perform laboratory tests and ensure compliance with regulatory guidelines. The ideal candidate has a Master’s or Bachelor’s degree in Chemistry and at least 3 years of experience in Quality Control within the pharmaceutical industry. Knowledge of GMP and analytical techniques is essential. This position offers the opportunity to contribute to innovative product quality and improvements.

Qualifications

• Minimum of 3 years in Quality Control within the pharmaceutical industry.
• Strong 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 Materials and Finished Products.
• Document and report results in accordance with GMP and GLP.
• Participate in method validation protocols ensuring compliance.

Skills

Wet chemistry techniques

GMP knowledge

GLP knowledge

Analytical techniques

Problem-solving skills

Excellent communication

Education

Master’s or Bachelor’s degree in Science, majoring in Chemistry

Tools

HPLC

UV spectroscopy

GC

LC-MS

IR spectroscopy

Job description

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 product line includes innovative and generic products as well as over-the-counter products, exported to several countries worldwide.

The position involves comprehensive wet chemistry techniques, including dissolution, HPLC, and UV testing on raw materials, in-process, final products, and stability samples, following established SOPs and pharmacopoeia specifications.

As a QC Analyst, you will be:

• Performing tests for Certification of Analysis of Raw Materials, Finished Products, and Stability Samples
• Documenting and reporting results in accordance with GMP and GLP
• Participating in method validation protocols and reports accurately and timely, ensuring compliance with laboratory SOPs, product specifications, and regulatory guidelines
• Participating in method development and validation/verification for API and finished products
• Resolving issues related to laboratory analysis and instrumentation
• Ensuring all work complies with regulatory, safety, and compliance requirements
• Investigating unexpected issues in developmental and regular products and providing solutions
• Revising and updating existing methods as needed
• Contributing to the development and improvement of SOPs and procedures

Education and competencies:

• Education: Master’s or Bachelor’s degree in Science, majoring in Chemistry
• Experience: Minimum of 3 years in Quality Control within the pharmaceutical industry
• Specialized Training: Strong knowledge of GMP, GLP, analytical techniques, and method validation
• Technical Knowledge: Chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, LC-MS, AA, TOC, etc.
• Regulatory Understanding: Current GMP, ICH, and FDA requirements
• Skills: Excellent organizational, problem-solving, and computer skills
• Languages: Excellent oral and written communication skills in English and French
• Teamwork: Willingness to work collaboratively in a team environment