Job Description

Specialist, Quality Assurance and Regulatory Affairs - REMOTE
Job Locations
CA-ON-Toronto
Position Type Full Time
Postal Code
M5B 2L7 Requisition ID 2023-429575 Category Creative & Product Services
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 Duties and Responsibilities
Quality Assurance/Quality Control:
\xc2\xb7 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.
\xc2\xb7 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.
\xc2\xb7 Reviews production and laboratory records.
\xc2\xb7 Perform Quality Control duties as stated in the Standard Operating Procedures on Quality Control.
\xc2\xb7 Liaison with third party Quality and Regulatory Designate as it pertains to medical device, drug, cosmetic and natural health products.
\xc2\xb7 Maintain accurate GMP records for the product.
\xc2\xb7 Ensure that no medical device, drug, cosmetic and natural health products is released for sale unless it is compliant with the GMPs.
\xc2\xb7 Support and Assist 2(two) Quality and Regulatory Associate Managers as required.
Regulatory Affairs:
\xc2\xb7 Keep an up-to-date knowledge on Health Canada regulations.
\xc2\xb7 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
\xc2\xb7 2+ Years of experience in compliance, quality assurance, regulatory affairs, and document management in the pharmaceutical or non-prescription drug industry or equivalent.
\xc2\xb7 Experience in an environment adhering to Health Canada regulations.
\xc2\xb7 GMP pharma experience.
\xc2\xb7 Prior experience with quality release for natural health products, medical devices, drugs, and cosmetics.
\xc2\xb7 Experience in document control and management.

Skills, Knowledge, and Abilities
\xc2\xb7 Ability to understand technical documents, processes, regulations, industry standards, procedures, and processes.
\xc2\xb7 Great communication skills.
\xc2\xb7 Analytical, methodical, and diligent with good planning abilities.
\xc2\xb7 Ability to effectively work both independently and in a team environment.
\xc2\xb7 Good time management and organizational skills.
\xc2\xb7 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.

The Company is committed to providing equal opportunity in all employment practices without regard to race, nation or ethnic origin, colour, religion, age, sex

...

(including pregnancy and childbearing), sexual orientation, marital status, family status, physical or mental disability or pardoned criminal convictions, or any other category protected by law.

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. The Company reserves the right at any time with or without notice to alter or change job responsibilities, reassign or transfer job position or assign additional job responsibilities. The Company shall provide reasonable accommodations of known disabilities to enable a qualified applicant or employee to apply for employment, perform the essential functions of the job, or enjoy the benefits and privileges of employment as required by the law.

Employee understands that neither the provision of the 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.

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