Senior QA Associate - Biologics Fill Finish (cGMP)

Eurofins Canada BioPharma; Mississauga; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading life sciences company in Mississauga is seeking a Senior QA Associate for their Biologics and Fill Finish operations. This role involves ensuring compliance with cGMP and overseeing the production of critical biological therapies. Candidates should have a BSc in Biochemistry or Microbiology, along with 2-5 years of pharmaceutical quality experience. Excellent benefits and a collaborative environment await the right candidate.

Benefits

Health & dental coverage

Life and disability insurance

Paid holidays and time off

RRSP with 3% company match

Qualifications

• 2-5 years of pharmaceutical quality experience.
• Strong understanding of cGMP and related regulations.
• Experience with biologic pharmaceuticals, particularly mAbs and ADCs is an asset.
• Sterile fill/aseptic processing experience preferred.

Responsibilities

• Ensure compliance with Current Good Manufacturing Practices (cGMP).
• Oversee quality in production line clearance and batch manufacturing.
• Review and approve cGMP analytical data.
• Support deviation investigations and laboratory investigations.
• Contribute to QMS development and continuous improvement.

Skills

Attention to detail

Project management

Interpersonal skills

Multi-tasking

Time management

Written and verbal communication

Education

BSc in Biochemistry, Microbiology, or related discipline

Job description

A leading life sciences company in Mississauga is seeking a Senior QA Associate for their Biologics and Fill Finish operations. This role involves ensuring compliance with cGMP and overseeing the production of critical biological therapies. Candidates should have a BSc in Biochemistry or Microbiology, along with 2-5 years of pharmaceutical quality experience. Excellent benefits and a collaborative environment await the right candidate.