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Quality Assurance Specialist

2 months ago

Oakville, Ontario, Canada BioScript Solutions Full time

Your future begins here

The Quality Assurance and Regulatory Specialist plays a crucial role in supporting the Manager of Quality Assurance at BioScript Solutions. This position is essential for ensuring that quality operations align with the standards set by both BioScript Solutions and its clients.

Key Responsibilities

  • Review and validate receiving documentation for 3PL/Wholesale regarding DIN and Medical Device transactions, ensuring accurate forwarding to clients and final release in the Warehouse Management System (WMS).
  • Prepare and revise controlled documents, including Client Notes, Standard Operating Procedures (SOPs), work instructions, training materials, and forms.
  • Collaborate with the HR Operations Team to update and maintain Organizational Charts and Job Descriptions.
  • Assist the Quality Assurance Manager during Regulatory Inspections and Client audits as necessary.
  • Prepare documentation for labeling projects and support operational activities related to labeling management.
  • Help in the preparation and editing of returns, complaints, deviations, Corrective and Preventive Actions (CAPAs), and change controls.
  • Participate in Vendor Management, including conducting vendor audits and qualifications.
  • Review temperature monitoring graphs, manage alerts and alarms for the warehouse, and ensure sensor calibration records are current.
  • Oversee facility preventative maintenance in accordance with internal standards.
  • Contribute to special Quality Assurance projects as assigned.
  • Support ongoing training initiatives and compliance training.
  • Conduct reviews and assessments of stability data to ensure adherence to regulatory requirements.
  • Assist in recall and mock recall activities, ensuring compliance with regulatory standards.
  • Ensure compliance with Canadian Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDP).
  • Maintain compliance with regulatory requirements for the product portfolio on behalf of BioScript Solutions and its clients.
  • Manage post-approval compliance activities, including annual DIN renewals and label reviews.

Qualifications

  • Bachelor's Degree in Science, preferably in Chemistry, Microbiology, or Life Sciences.
  • Post Graduate Certificate in Regulatory Affairs or equivalent experience is an asset.
  • 2-3 years of experience in Quality Assurance, particularly in 3PL, Wholesale, and Importation for Drug and Medical Device Products.
  • 2-3 years of experience in Canadian Regulatory Affairs.
  • Strong scientific, quality, and regulatory knowledge.
  • Excellent written and verbal communication skills.
  • Effective time management abilities.
  • Proficient in managing multiple projects and changing priorities while meeting strict deadlines.
  • Ability to identify compliance risks.
  • Strong computer skills, including proficiency in Word, Excel, Teams, PDF, Electronic Signatures, SharePoint, and WMS systems.

At BioScript Solutions, we are committed to sustainability, with one tree planted for every new hire, contributing to a greener future.

Job Status: Full Time Permanent

Job Location: Onsite