Senior Specialist, Quality Assurance

BlueRock Therapeutics; Toronto; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading biotechnology company in Toronto seeks a Quality Assurance Senior Specialist to ensure compliance with regulatory standards and oversee GMP operations. The ideal candidate will possess a strong background in quality management and biological sciences, along with excellent organizational and problem-solving skills to effectively oversee quality initiatives and team leadership.

Qualifications

• 8+ years relevant experience required or 6+ years with a Master's degree.
• Experience with biologics highly desired.
• Experience supervising GMP operations.

Responsibilities

• Draft and approve cGMP documents, coordinate quality investigations.
• Audit compliance to SOPs and conduct external audits.
• Manage electronic Quality Management System.

Skills

Technical writing

Detail-oriented

Organizational skills

Problem solving

Education

Bachelor's degree in Biological Sciences

Master's degree (if applicable)

Tools

MS Office (Word, Excel, SharePoint, Access, Adobe Acrobat)

Job description

The Quality Assurance Senior Specialist works with the established Quality Management System to support the manufacture, testing and release of BlueRock’s investigational products. In addition to quality oversight, duties include writing new Standard Operating Procedures and coordinating the revision, review, and approval of SOPs and other GMP documents that are necessary for ensuring compliance with applicable , Canadian and global standards.

Responsibilities :

• Work with team members to draft, review and approve cGMP documents including, specifications and protocols for qualification and validation studies. Coordinate review, approval, and archiving of qualification and validation reports.
• Assist in Quality Investigations by coordinating OOS and Deviation investigations and executing CAPA procedures including facilitating identification of root cause, risk assessments and implementing corrective actions with monitoring for effectiveness.
• Perform risk assessments and close out of engineering work orders for equipment and areas used for cGMP manufacturing.
• Audit internal facilities and systems for compliance to SOPs, cGMP regulations, and other applicable regulations.
• Participate in audits by external clients and regulatory authorities.
• Assist in the management and maintenance of the electronic Quality Management System.
• Issue and reconcile labels for final product.
• Perform batch record review and product release.
• Participate in Technology Transfers to the BlueRock MaRS7 / PMCRT facilities.
• Manufacturing support and oversight for both MaRS7 and PMCRT facilities.
• Other duties as assigned.

Minimum Requirements :

• Minimum of a Bachelor’s degree in Biological Sciences or related field with a minimum of 8+ years of relevant experience in the industry is required OR a Master’s degree with 6+ years relevant experience is required.
• Previous experience with biologics is highly desired.
• Experience supervising a team of associates supporting GMP operations is required.
• Experience with deviations, investigations, CAPA and change control and electronic quality management systems is desired.
• Must be detail-oriented with excellent organizational skills.
• Strong technical writing skills with working knowledge of MS office programs, such as Word, Excel, SharePoint, Access and Adobe Acrobat professional are required.
• Must be self-motivated with the demonstrated ability to work effectively with people from multiple departments, ensure deadlines are met, and manage multiple, potentially changing, priorities.
• Proven ability to identify quality issues and effectively and proactively resolve issues in a team setting.

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Quality Assurance Specialist • Toronto, Ontario