Senior QA Associate (BiologicsFill Finish) Eurofins CDMO Alphora, Inc.
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Job Location:
Mississauga - Canada
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Are you passionate about quality and innovation in pharmaceutical manufacturing At Eurofins CDMO Alphora Inc. were looking for a Senior QA Associate to be a key player in our Biologics and Fill Finish operations. This is more than a jobits a chance to make a real impact on the development of life-changing therapies for patients around the world.
In this role youll be at the forefront of ensuring compliance with Current Good Manufacturing Practices (cGMP) supporting the production of safe and effective clinical and commercial biologics. Youll 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 wed love to hear from you.
What Youll 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 :
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
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 .
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
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
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Continuous Integration
- Quality Assurance
- FDA Regulations
- Root cause Analysis
- TFS
- Food Processing
- ICH Q10
- Jira
- Software Testing
- Quality Management
- Selenium
- Github
About Company
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 the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
