Kelly Services Quality Assurance Associate - Pharma in Toronto, Canada

Kelly Scientific Resources (KSR) is a specialty service of Kelly Services, Inc., a leader in providing workforce solutions. Since its launch in 1995, KSR has provided staffing and placement services to a broad spectrum of industries, including biotechnology, chemical, consumer products, cosmetics, environmental, food sciences, medical/clinical, pharmaceutical, and petrochemical. Today, KSR leads the world in dedicated scientific and clinical research staffing. Visit at to learn more and view a full listing of our opportunities.


The Quality Assurance Associate is trusted to work in compliance with all applicable GMP’s to support the release of safe and on time drug products. In addition, the QA Associate is accountable for completing quality Assurance tasks related to contract manufacturing organizations, (CMO’s), contract labs, production and packaging personnel and supply chain.

Job Requirements:

Minimum Bachelor Degree in science (Chemistry or Life sciences) or equivalent experience

5-7 years of practical experience in the pharmaceutical industry in the areas of QA performing commercial batch release

Experience working in a pharmaceutical quality systems environment (i.e. deviations, CAPA, Change Control, SOP’s etc.)

Experience with of Good Documentation Practices and Canadian GMP’s and Quality Systems

Experience with US FDA GMP’s an asset

Strong computer skills i.e. MS Office

Effectively communicates in English (oral and written)

Well-developed organizational /planning skills


QA Release Support

Prepare finished Products, excipients and API batch documents for release

Perform Packaging Line Clearances

Perform incoming inspection of drug products

Perform in-process checking during packaging

Track and Investigate product related deviations

Track product related CAPA records

Track Customer complaints

Document Stock returns

Respond to Customer Complaints

Sample finished product for testing

Quality Systems Support

Track and Investigate Quality systems deviations

Track quality system CAPAs implementation and effectiveness

Perform Audits as required

Review Artwork

Creates, revises, and reviews SOPs including compliance documentation initiation, revisions, and deletions.

Maintain the master documents system

Track and respond to customer complaints

Maintain the site training database

Create and track Change Controls

Conducts internal cGMP audits and follow up to any findings. Assists in the writing of detailed reports and analyzes quality data.

Production/Manufacturing Support

Maintains the training system

Assists in the training of new employees as needed.

R&D QA Support (Not required, but an Asset to have)

Review executed batch records for Stability/Submission batches

Review method analytical validation reports and protocols

Review and approve R&D deviation reports and Lab investigation reports

Review and approve stability summary reports

Assist with audits of Contract Manufacturing Organizations