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Associate Manager Quality Assurance Ra

7 months ago

Edmonton, Canada Advantage Solutions Full time

Summary:
**Associate Manager QA RA**

The Associate Manager, Quality Assurance (QA) & Regulatory Affairs (RA) 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.

**Essential Job Duties and Responsibilities**

**Job Duty**

Quality Assurance/Quality Control:

- Performs all 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, Stability, etc., for products marketed.
- Reviews production and laboratory records, assisting in internal audits and self-inspections.
- Supports in the development of SOPs to ensure efficient and compliant External Quality function.
- Perform Quality Control duties as stated in the Standard Operating Procedures on Quality Control.
- Ensure that all medical device, drug, natural health product and cosmetic products released is of intact product integrity.
- Liaison with the suppliers of the Advantage Solutions Inc.’s medical device and/or drug and/or natural health and/or cosmetic products.
- Liaison with third party Quality and Regulatory Designate.
- Liaison with the contract warehouse as it pertains to the Advantage Solutions Inc.’s medical device, drug, cosmetic and natural health products.
- Always adhere to the Standard Operating Procedures for the Good Manufacturing Practices operations of Advantage Solutions Inc.
- 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.

Regulatory Affairs:

- Reviews regulatory documentation and submissions to regulatory bodies including, but not limited to: Drug Establishment Licence, Medical Device Establishment Licence and Site Licence.

**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 essential duties and function of this job
- Travel up to 5%

Minimum Qualifications The following are the minimum job-related qualifications which an individual needs in order to successfully perform the essential duties and responsibilities of the job

Education Level: (required): Bachelor's Degree or equivalent experience

**Field of Study/Area of Experience**:

- 5+ 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 federal governmental regulation (i.e: Health Canada)
- Strong GMP pharma/ Qualified Person in Charge (QPIC) experience.
- Prior experience interacting with auditors and regulators.
- Experience in document control and management.
- Experience with preparing regulatory submissions is an asset.

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

**Environmental & Physical Requirements**

Administrative Requirements

Incumbent must be able to perform the essential functions of the job. Work will be performed at head office or warehouse environment. The use of proper safety practices when handling the products is essential.

**Additional Information Regarding ASM Job Duties and Job Descriptions**

Employee understands that neither the provision of the Job Description nor any representation in this