QA Associate – Biologics

About the role

Eurofins CDMO Alphora develops and manufactures therapeutics for global pharmaceutical and biotech clients, producing bulk drug substances and finished dosage forms for clinical trials and commercial use. The QA Associate – Biologics supports quality oversight of GMP activities in the Biologics unit, including monoclonal antibodies, mammalian therapeutic proteins and antibody-drug conjugates, and ensures compliance with cGMP. The role reports to the QA Manager, Biologics.

Key responsibilities

• Quality oversight: production support, equipment and line clearances, batch manufacturing and packaging oversight, change control review, logbook issuance, GDP inspections, environmental monitoring and contamination control strategy
• Batch review and release: check batch records and cleaning studies, assign batch disposition, compile release documentation
• Testing data review: approve analytical data and protocols for qualification, stability, method qualification and validation, and QC data for raw materials, in-process controls and finished products
• Deviations and investigations: support investigation plans, root cause analysis, CAPA and final reports
• QMS support: contribute to SOPs, quality system improvements and continuous improvement
• Audit support: help prepare customer and regulatory audits and lead internal audits
• Client collaboration and representation of Alphora QA on client projects

Required profile

• BSc, preferably in Biochemistry, Microbiology or a related discipline
• 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 biologics, especially mAbs and ADCs, is an asset; sterile fill/aseptic processing experience preferred
• Strong written and verbal skills, multitasking, interpersonal, time and project management skills, attention to detail, and a goal-oriented approach

What we offer

• Starting annual base compensation of $70,000 CAD, with total compensation depending on experience and skills
• Health and dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays and paid time off