Quality Assurance Specialist

4 weeks ago

Oakville, Ontario, Canada BioScript Solutions Full time

Your future begins here

The Quality Assurance and Regulatory Specialist plays a vital role within BioScript Solutions, reporting directly to the Quality Assurance Manager. This position is essential in ensuring the integrity of quality operations and compliance with industry standards.

Key Responsibilities

  • Review and validate receiving documentation for third-party logistics and wholesale operations, ensuring compliance with regulatory requirements.
  • Prepare and maintain controlled documents, including Standard Operating Procedures (SOPs), training materials, and client communications.
  • Collaborate with the Human Resources Operations Team to update and maintain organizational charts and job descriptions.
  • Assist the Quality Assurance Manager during regulatory inspections and client audits.
  • Prepare documentation for labeling projects and support operational activities related to labeling management.
  • Contribute to the preparation and review of returns, complaints, deviations, CAPAs, and change controls.
  • Engage in vendor management, including conducting audits and qualifications.
  • Monitor temperature logs and sensor calibration records, ensuring compliance with internal requirements.
  • Participate in special Quality Assurance projects as assigned.
  • Support ongoing training initiatives and ensure compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
  • Conduct reviews of stability data to ensure adherence to regulatory standards.
  • Assist in recall and mock recall activities, ensuring timely execution to maintain compliance.
  • Ensure compliance with Canadian GMPs and GDPs, maintaining the integrity of the product portfolio.
  • Manage licensing requirements and prepare applications for new product needs.
  • Oversee post-approval compliance activities, including annual renewals and label reviews.

Qualifications

  • Bachelor's degree in Science, preferably in Chemistry, Microbiology, or Life Sciences.
  • Postgraduate certificate in Regulatory Affairs or equivalent experience is advantageous.
  • 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 skills, with the ability to handle multiple projects and shifting priorities.
  • Proficient in identifying 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 initiatives such as planting a tree for every new hire, contributing to a greener future.

Job Status: Full Time Permanent

Job Location: Onsite

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