Job#: 3039489

Job Description:

Specialist III, Internal Quality Operations

Position: Specialist III, Internal Quality Operations

Client: Innovative Biopharma client

Contract/Perm & duration: 12-month contract (potential for extension)

Location: Downtown Toronto, 5 days/week onsite

Pay rate: $40-52 /hr

We are seeking a highly motivated individual to join our innovative Biopharma client as a Specialist III in the Quality Assurance (QA) department reporting to the Associate Director, Quality Assurance. This position will be responsible for ensuring quality of GMP activities at the Toronto GMP manufacturing and testing facilities for aseptically produced investigational cell and gene therapy products. This position will work with a diverse group of internal partners.

Responsibilities:

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. Work with team members to 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.

Key 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 Highly adaptable and skilled problem solver with a proactive attitude comfortable with ambiguity Experience working with CxOs and contract testing labs preferred Ability and willingness to work in alternate time zones, if required (ie. early morning, late evening, possibly overnight)

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Everforth Apex Benefits Overview: In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA.

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