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Quality Assurance Specialist
3 months ago
Your career journey 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 designed to ensure that quality operations align with the standards of both BioScript Solutions and its clients.
Key Responsibilities
- Review incoming documentation for 3PL/Wholesale concerning DIN and Medical Device receipts, ensuring proper forwarding to clients and final approval 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 operations in executing and managing labeling activities.
- Help in drafting and reviewing returns, complaints, deviations, Corrective and Preventive Actions (CAPAs), and change controls.
- Support Vendor Management activities, including vendor audits and qualifications.
- Analyze temperature monitoring graphs, manage alerts and alarms for the warehouse, and ensure sensor calibration records are up-to-date.
- Review facility maintenance procedures in accordance with internal requirements.
- Participate in special Quality Assurance projects as assigned.
- Support ongoing training initiatives and ensure compliance with Annual Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) 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 GMPs and GDP.
- Maintain current licenses and prepare applications for new regulatory requirements for a variety of products, including Wholesale and Importation activities.
- Ensure that post-approval compliance activities are documented and completed, including annual DIN renewals, DEL submissions, MAH applications, label reviews, Annual Product Quality Reviews (APQRs), and updates to Product Monographs.
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.
- Strong time management abilities.
- Adept at managing multiple projects and adapting to changing priorities while meeting strict deadlines.
- Ability to identify compliance risks effectively.
- Proficient in computer applications including 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
