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 www.kellyscientific.com at http://www.kellyscientific.com/ to learn more and view a full listing of our opportunities.
QUALITY ASSURANCE ASSOCIATE
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.
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
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.
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