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Specialist, Quality Assurance and Regulatory

4 months ago

Toronto, Canada Advantage Solutions Full time

Summary:
Quality Assurance (QA) & Regulatory Affairs (RA) Specialist

The Quality Assurance (QA) & Regulatory Affairs (RA) Specialist is responsible for several aspects of Quality Assurance and Regulatory Affairs as it relates to Drugs, Natural Health Products, Cosmetics and Medical Devices that are imported and/or distributed by Advantage Solutions Inc.

**Responsibilities**:
Advantage Sales and Marketing LLC dba Advantage Solutions is one of North America’s leading sales and marketing agencies specializing in outsourced sales, merchandising, category management and marketing services to manufacturers, suppliers and producers of food products and consumer packaged goods. Advantage Solutions services a variety of trade channels including grocery, mass merchandise, specialty, convenience, drug, dollar, club, hardware, consumer electronics and home centers. We bridge the gap between manufacturers and retailers, providing consumers access to the best products available in the marketplace today.

Position Summary

The Quality Assurance (QA) & Regulatory Affairs (RA) Specialist is responsible for several aspects of Quality Assurance and Regulatory Affairs as it relates to Drugs, Natural Health Products, Cosmetics and Medical Devices that are imported and/or distributed by Advantage Solutions Inc.

Essential Job

**Responsibilities**:
Quality Assurance/Quality Control:

- Performs QA functions including, but not limited to batch/lot record review and release, raw data review, deviation/failure investigation, change evaluation, product sampling, and retention.
- Conduct a review of and track Good Manufacturing Practices (GMP)

documentation, including Master Batch Records, Certificates of Analysis, Annual Product Quality Reviews, etc., for products marketed.
- Reviews production and laboratory records.
- Perform Quality Control duties as stated in the Standard Operating Procedures on Quality Control.
- Liaison with third party Quality and Regulatory Designate as it pertains to medical device, drug, cosmetic and natural health products.
- Maintain accurate GMP records for the product.
- Ensure that no medical device, drug, cosmetic and natural health products is released for sale unless it is compliant with the GMPs.
- Support and Assist 2(two) Quality and Regulatory Associate Managers as required.

Regulatory Affairs:

- Keep an up-to-date knowledge on Health Canada regulations.
- Support Regulatory Site Licences as required.

Supervisory Responsibilities

Direct Reports
- This position does not have supervisory responsibilities for direct reports

Indirect Reports
- This position does not have guidance or mentoring responsibilities for indirect reports

Travel and/or Driving Requirements
- Travel and Driving are not essential duties or functions of this job

Minimum Qualifications

The following are the minimum job-related qualifications which an individual requires in order to successfully

perform the essential duties and responsibilities of the job.

Education Level: (required): Bachelor's Degree

Field of Study/Area of Experience: Chemistry, chemical engineering, biochemistry, physical sciences, life

sciences, pharmacology, or pharmacy
- 2+ Years of experience in compliance, quality assurance, regulatory affairs, and document management in the pharmaceutical or non-prescription drug industry or equivalent.
- Experience in an environment adhering to Health Canada regulations.
- GMP pharma experience.
- Prior experience with quality release for natural health products, medical devices, drugs, and cosmetics.
- Experience in document control and management.

Skills, Knowledge, and Abilities
- Ability to understand technical documents, processes, regulations, industry standards, procedures, and processes.
- Great communication skills.
- Analytical, methodical, and diligent with good planning abilities.
- Ability to effectively work both independently and in a team environment.
- Good time management and organizational skills.
- Knowledge of current good manufacturing regulations as applicable to the pharmaceutical industry, specifically Health Canada.

Environmental & Physical Requirements

Office / Sedentary Requirements

Incumbent must be able to perform the essential functions of the job. Work is performed primarily in an office environment. Typically requires the ability to sit for extended periods of time (66%+ each day), ability to hear the telephone, ability to enter data on a computer and may also require the ability to lift up to 5 kilograms.

Employee understands that neither the provision of the Job Description nor any representation in this document creates a guarantee or contract of employment for any specified period of time or changes the nature of Employee’s employment, which can only be modified in a writing signed by the CEO.

Important Information:
The above statements are intended to describe the general nature and level of work being performed by people assigned to this position. They are