QA Associate – Biologics: GMP Compliance & QC

Eurofins; Mississauga; On-site; CAD 63,000 - 77,000; Full time

Benefits offered by this job

Health & dental coverage

Life and disability insurance

RRSP with 3% company match

Paid holidays

Paid time off

Job summary

Eurofins CDMO Alphora Inc. is seeking a QA Associate – Biologics to support cGMP compliance and ensure safety and efficacy of clinical and commercial biologics.

The role focuses on providing quality oversight across GMP activities within the Biologics unit, including sterile and analytical operations. The successful candidate will assist in batch release, documentation, deviations, and CAPA while collaborating with cross-functional teams to maintain compliance and continuous improvement

Qualifications

• BSc; specialization in Biochemistry, Microbiology, or related discipline is preferred.
• 2-5 years of pharmaceutical quality experience.
• Experience with development, manufacture, packaging and testing of pharmaceuticals.
• Strong understanding of cGMP and related Regulations.
• Experience with Biologic pharmaceutical, in particular mAbs and ADCs is an asset.
• Sterile fill/aseptic processing experience preferred.
• Strong written and verbal skills are a priority.

Responsibilities

• Provide QA oversight across GMP activities within Biologics operations.
• Oversee batch records, deviations, change controls and release activities.
• Support logbook issuance, reconciliation, and GDP inspections.
• Contribute to development/implementation of quality systems and CAPA.
• Assist in audits and supplier quality activities.
• Contribute to QA department meetings and client projects.

Skills

Quality Assurance

cGMP knowledge

Biologics familiarity

Quality documentation

Education

BSc; Biochemistry/Microbiology specialization

Job description

Eurofins CDMO Alphora Inc. is seeking a QA Associate – Biologics to support cGMP compliance and ensure safety and efficacy of clinical and commercial biologics.

The role focuses on providing quality oversight across GMP activities within the Biologics unit, including sterile and analytical operations. The successful candidate will assist in batch release, documentation, deviations, and CAPA while collaborating with cross-functional teams to maintain compliance and continuous improvement