Specialist III, Internal Quality Operations

Apex Systems; Toronto; On-site; CAD 55,000 - 72,000; Full time

Job summary

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.

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.
• 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.

Skills

cGMP knowledge

Biopharma experience

Quality Assurance

Documentation review

CAPA investigations

Education

Life Sciences degree

Job description

Job Description

Specialist III, Internal Quality Operations

Job#: 3056423

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 an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

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