QC Analyst (Raw Materials)

Anter Consulting; Alberta; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading consulting firm in Alberta is seeking a Quality Control Analyst to perform testing of raw material samples and ensure compliance with cGMP regulations. The role involves managing samples, conducting stability testing, and participating in audits. Ideal candidates will have experience in analytical testing and familiarity with regulatory standards. This position offers a dynamic work environment focused on quality assurance.

Qualifications

• Experience with analytical testing methodologies.
• Knowledge of cGMP regulations.
• Ability to manage samples and documentation.

Responsibilities

• Perform testing of incoming raw material samples.
• Manage and store raw material samples compliant with cGMP.
• Conduct stability testing and maintain QC laboratory.

Job description

• Perform testing of incoming raw material samples (e.g., FTIR, identity by wet chemistry, reagent preparation, sample receiving).
• Manage and store raw material samples in compliance with cGMP.
• Perform analytical testing and documentation for raw materials, API, drug substances/products, packaging materials, complaints, and stability samples.
• Conduct stability testing, sample storage, and documentation (if not centralized).
• Maintain QC Raw Materials laboratory in full cGMP compliance.
• Execute method validation/verification and routine release testing for raw materials.
• Perform data entry and review of RM packages for batch release.
• Support laboratory improvement projects, investigations (OOS, deviations), and change controls.
• Prepare for and participate in internal audits and health authority inspections.
• Undertake other duties or projects as assigned by the Section Manager.

HSE

• Comply with all HSE policies and guidelines.
• Identify, report, and propose solutions for potential hazards and risks.
• Actively participate in initial and ongoing safety training.