Senior QA Associate (Biologics/Fill Finish) - Eurofins CDMO Alphora, Inc.

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

Job summary

A leading pharmaceutical company in Mississauga seeks a Senior QA Associate to ensure compliance and support production in biologics operations. The ideal candidate holds a BSc in Biochemistry or Microbiology and has 2-5 years of quality experience. This role offers hands-on experience and the opportunity to work with innovative therapies and technologies focused on improving patient health.

Benefits

Health & dental coverage

Life and disability insurance

RRSP with 3% company match

Paid holidays

Paid time off

Qualifications

• 2-5 years of pharmaceutical quality experience.
• Strong understanding of cGMP and related regulations.
• Experience with biologic pharmaceuticals, particularly mAbs and ADCs.

Responsibilities

• Oversight of production line clearance and final product packaging operations.
• Review and release of executed batch records.
• Support deviation investigations and laboratory investigations.
• Contribute to QMS development and continuous improvement.
• Prepare for customer and regulatory audits.

Skills

Quality Oversight

Batch Review and Release

Testing Data Review

Deviations and Investigations

QMS Support

Strong written and verbal skills

Education

BSc in Biochemistry, Microbiology, or related discipline

Job description

Overview

Eurofins CDMO Alphora Inc. develops and manufactures new therapeutics to improve the lives and health of patients. Eurofins CDMO Alphora provides contract research & development services to global pharmaceutical and biotech companies, developing their processes and manufacturing their bulk drug substances (Active Pharmaceutical Ingredients -“API’s”) as well as finished dosage products (tablets, capsules, suspensions) for supply to clinical trials and commercial requirements. Eurofins CDMO Alphora provides a rich and technologically challenging environment with a continuing flow of interesting projects. Our employees work in close concert with clients throughout the development process to achieve their program objectives. Eurofins CDMO Alphora Inc. is growing its state-of-the-art organization, with continued investments in modern facilities, equipment, and instrumentation while providing a rich environment for employees to develop their technical skills and careers paths.

Are you passionate about quality and innovation in pharmaceutical manufacturing? At Eurofins CDMO Alphora Inc., we’re looking for a Senior QA Associate to be a key player in our Biologics and Fill Finish operations. This is more than a job—it’s a chance to make a real impact on the development of life-changing therapies for patients around the world.

In this role, you’ll be at the forefront of ensuring compliance with Current Good Manufacturing Practices (cGMP), supporting the production of safe and effective clinical and commercial biologics. You’ll work closely with cutting-edge technologies and products, including monoclonal antibodies (mAbs), therapeutic proteins, and antibody drug conjugates (ADCs).

What makes this opportunity exciting?

• Hands-on experience in biologics manufacturing and fill-finish operations
• Exposure to projects across all phases of the pharmaceutical product lifecycle
• A dynamic, fast-paced environment where learning and growth are constant
• The chance to tackle unique challenges and contribute to meaningful solutions

What You’ll do:

• Quality Oversight: Production line clearance; Batch manufacturing and final product packaging operation oversight; Change control management; Logbook management; GDP oversight; Participate/lead quality oversight initiatives as assigned.
• Batch Review and Release: Review executed batch records and equipment cleaning records; Batch disposition assignment; Preparation of batch certificates
• Testing Data Review and Release: Review/approve cGMP analytical data supporting reference standard qualification and method qualification/validation; Review/approve quality control lab data for raw materials, in-process controls, intermediates and APIs; Assign disposition to laboratory samples
• Deviations and Investigations: Support deviation investigations and laboratory investigations; Development of investigation plans; Conducting investigations; Root cause analysis; Risk and impact assessments; CAPA determination
• QMS Support: Contribute to QMS development and continuous improvement; Contribute to writing and review of over Standard Operating Procedures (SOPs).
• Audit Support: Assist in preparation/coordination of customer and regulatory agency audits.
• Contribute to QA department meetings by providing project status reports as well as identifying and leading continuous improvement activities
• Participate in opportunities to develop knowledge of CGMP and business operations

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
• A proficiency for multi-tasking
• Excellent interpersonal skills
• Good time management and project management skills
• A focus on attention to detail
• Be goal orientated and results driven
• A desire to learn and for continuous development

Additional Information

• At Eurofins we offer excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, paid time off.
• Accommodation: Persons with disabilities who need accommodation in the application process, or those needing job postings in an alternative format, may e-mail a request via the website at Eurofins.ca.
• As a Eurofins employee, you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins, please explore our website at Eurofins.ca
• We thank all applicants within commuting distance of GTA, Ontario for showing an interest in this position. Only those selected for an interview will be contacted.
• This posting is supported by AI technology to assist in screening candidates and resumes.
• NO AGENCIES, CALLS OR EMAILS PLEASE