Quality Assurance Specialist

• Coordinate the day-to-day Quality Assurance release activities associated with 3PL operations (i.e.. receipt, inspection, review and disposition) in accordance with the GMPs and all other contractual obligations.
• Coordinate with clients and/or foreign sites, or other internal departments, with product launch activities, the compilation of complete GMP Quality documents to support the importation of client products. Provide Quality Assurance guidance and support to potential new clients or new products as assigned.
• Assist QA Management with the management of both the deviation program, the change control program and, CAPA program, acting as a Team Lead when required. Provide input relating to the initiation, investigation, root cause analysis and the identification of corrective and preventive actions. The Senior QA Specialist will have the authority to review and approve change control documents and deviation reports if so designated by Senior QA Management.
• Assist QA Management in the preparation of routine key quality performance indicators (KPIs) to generate client specific report metrics, acting as a Team Lead when required.
• Assist QA Management in the development/revision and implementation of QA policies and procedures, acting as a Team Lead when required.
• Assist QA Management during the execution of Product Recalls, including customer notification, coordination of customer returns and maintaining documentation, acting as a Team Lead when required.
• Develop effective relationships with Operations Team in order to ensure that the Milton Warehouse and Innomar DCs are maintained in a state of GMP compliance.
• Perform timely review and assessment of documents received from clients/foreign sites, including but not limited to manufacturing and packaging records, Certificates of Analysis, Certificates of Manufacture, and other product release documents.
• Perform quality and regulatory reviews and oversight on imported products as assigned making quality decisions and addressing or resolving problems based on analysis and consultation with clients.
• Participate and complete Internal Audits as part of the Internal Audit Program, acting as Lead Auditor when required.
• Actively contribute to the development, maintenance and improvement of the Innomar GMP Quality Systems. Act as Project Lead for Improvement Initiatives / Projects if assigned by QA Management.
• Support client, regulatory, corporate and internal audits as requested by Management.
• Provide support to the QPIC / RPIC (if requested) to help ensure the continued compliance of Innomar’s Milton Facility with Health Canada regulations on the control of Narcotics, Controlled Substances, Precursors and Cannabis products.
• Understand and apply company Confidentiality, Privacy and Quality Agreements.
• May be required to travels up to 20% of the time.
• Other duties and tasks that may, from time to time, be assigned by QA Management.
• May be required to be on standby/ on call as part of this role.

• Bachelor of Science degree in a pharmaceutical or healthcare related field (e.g. chemistry, microbiology, pharmacy, and pharmacology).

• Minimum of 2 years’ experience in Quality Assurance or Quality Compliance.
• Experience working in a GMP Operations/Warehouse environment is considered an asset.
• Regulatory Affairs or Quality Assurance Certification is considered an asset.
• Experience in supporting Regulatory or client audits is considered an asset.

• Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP regulations and associated guidelines.
• Demonstrated ability to assess/manage risk in a quality operations environment.
• The ability to identify pragmatic solutions to compliance/operational problems and challenges.
• Demonstrated leadership, organizational, inter-personal, and communication skills (verbal and written).
• Proven ability to organize individual workloads, set priorities and multi-task in order to meet competing deadlines, with the ability to remain flexible, adaptable and responsive to changing business needs.
• Strong attention to detail, proven data analysis skills and the ability to present these findings effectively.
• Ability to work both independently and in a team environment, always promoting positive, respectful and professional relationships.
• Strong proficiency in common office applications (e.g. MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, etc.) and the ability to achieve rapid fluency in business related electronic applications / platforms (e.g., eQMS, EMS, WMS, CRM, etc.).

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