QA Specialist III, GMP Operations - Cell & Gene Therapy

Apex Systems; Toronto; Sur place; CAD 55 000 - 72 000; Plein temps

Résumé du poste

Everforth Apex in Downtown Toronto is hiring a Specialist III, Internal Quality Operations to lead GMP QA activities for aseptically produced investigational cell and gene therapy products. This onsite 12-month contract reports to the Associate Director, Quality Assurance.

The role requires 5+ years in pharma/biopharma or biotech with strong cGMP knowledge, and experience with GMP applications to production and QC testing of biologics or cell/gene therapy.

Qualifications

• Life Sciences-based BSc or advanced degree with a minimum of 5 years’ experience in pharma/biopharma or biotech with demonstrated knowledge of relevant cGMP regulations and operations in a GMP-regulated environment.
• Strong knowledge of GMP application to production and QC testing of biologics and aseptic processing, preferably with experience in cell and gene therapy.
• Strong knowledge of regulations and industry standards, including cGMP and applicable guidance documents, ICH guidance documents, USP, Ph. Eur, ISO and associated global regulations.
• Ability to support teams in meeting aggressive project timelines and to constructively engage team members in resolving conflicts.

Responsabilités

• Work with a team of internal and external quality specialists supporting the development and manufacturing of GMP cell and gene therapies produced at our client's facilities.
• Draft, review and approve GMP documents including specifications, Standard Operating Procedures and other quality control and manufacturing documents.
• 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 reviews and approvals of testing binders, CoAs, batch records and associated documents.
• Participate in Technology and Test Transfers to the client's facilities.
• Quality Control and Manufacturing support and oversight for both MaRS7 and PMCRT facilities.
• Participate in facility walkabouts, and internal and external audits.
• Other duties as assigned.

Connaissances

cGMP knowledge

Biopharma experience

Quality Assurance

Documentation review

CAPA investigations

Formation

Life Sciences degree

Description du poste

Everforth Apex in Downtown Toronto is hiring a Specialist III, Internal Quality Operations to lead GMP QA activities for aseptically produced investigational cell and gene therapy products. This onsite 12-month contract reports to the Associate Director, Quality Assurance.

The role requires 5+ years in pharma/biopharma or biotech with strong cGMP knowledge, and experience with GMP applications to production and QC testing of biologics or cell/gene therapy.