Company: AX Pharmaceutical Corp

Position: Quality Control Associate

Location: 100 Tesma Way, Unit 8, Concord, Ontario, Canada, L4K 0J9

Department: Quality and Compliance Department

Responsible to: Quality Control Manager

Position Summary:

The quality control associate’s primary responsibility is reviewing and approving batch certificates of analysis and ensuring that AX products meet appropriate pharmacopeia, regulatory and quality standards according to Health Canada and US FDA regulations, as well as USP and/or EP pharmacopeia standards. The quality control associate is responsible for preparing product SDSs and for reviewing and managing other product-related documents including stability data, methods of analysis, and packaging material documentation. This function maintains quality compliance with Current Good Manufacturing Practice (cGMP) and AX standard operating procedures (SOPs).

General Responsibilities:

- Transcription and review of Certificates of Analysis (CoA) from qualified contract manufacturers.

- Approve CoAs from contract manufacturers and update AX system.

- Verify that approved products are registered to AX Pharmaceutical’s DEL license prior to CoA approval.

- Complete change controls and deviations where required according to AX standard operating procedure.

- Ensuring that approvals are completed without delay; helping to facilitate efficient completion of orders for both incoming and outgoing product; conducting product/quality assessment for sales team inquiries

- Ensuring batch-to-batch consistency; verifying product shelf life against available stability data; ensuring required product documentation from qualified contract manufacturers is up to date (stability data, methods of analysis, and product packaging documentation).

- Analysis and comparison of methods of analysis with pharmacopeia and regulatory standards.

- Comparison and approval of packaging material specifications from product manufacturers with in-house packaging materials.

- Ensuring that all official company documentation is completed according to Good Documentation Practices and AX standard operating procedure.

- Managing and filing current SOPs; updating electronic and hard-copy versions as required; ensuring completion and documentation of training on SOP updates for all impacted staff (training is conducted by management staff).

- Familiarity and adherence to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and applicable regulatory guidelines from Health Canada and FDA

- Support of laboratory staff with minor duties as required (including but not limited to glassware washing, laboratory safety inspection, cleaning and temperature/humidity monitoring).

- Frequent intra-department and inter-departmental coordination with Quality Assurance, Procurement, Production, Sales, Laboratory and Shipping/Receiving teams.

- Performing all work in accordance with all established regulatory, compliance and safety requirements, and AX standard operating procedures

- The successful candidate is highly motivated and efficient, capable of working in a fast-paced environment and effectively meeting deadlines.

Working Conditions and Environment:

- normal business environment

- business casual attire

- working hours 9:00am - 5:00pm Monday to Friday

Skills and Qualifications:

Minimum post-secondary education in a related discipline.

Previous experience in a quality control role or previous experience in the pharmaceutical industry is preferred.

Previous experience in a GMP environment preferred.

Experience interpreting regulatory and guidance documents such as USP, FDA, Health Canada, and ICH.

Basic understanding of common pharmaceutical testing is preferred (assay, identification, impurities, water content, microbial bioburden, etc.).

Good understanding of Canadian Hazardous Products Regulations/WHMIS regulation.

Superior organizational and interpersonal skills

Ability to manage multiple projects and tasks concurrently and effectively

Excellent written and oral communication skills is a must

Computer proficiency with MS Office programs

Ability to meet deadlines and prioritize tasks with strong attention to detail

Behaviors aligned with AX Pharmaceutical Corp principles and values

AX Pharmaceutical Corp

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Quality Control Associate