Senior QA Associate – Biologics/Fill Finish

Eurofins CDMO Alphora is looking for a Senior QA Associate – Biologics/Fill Finish

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

If you thrive in a collaborative setting, enjoy solving complex problems, and are eager to grow your expertise in biologics QA, we’d love to hear from you.

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

The ideal candidate will have:

- 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

WHO ARE WE?

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.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 58,000 staff across a network of more than 1,000 independent companies in over 54 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

In 2023, Eurofins generated total revenues of EUR 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years.

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.

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 atwww.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.

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