Quality Assurance Associate (Drug Substance) - Eurofins CDMO Alphora, Inc

Eurofins

  • Mississauga, ON
  • Permanent
  • Temps-plein
  • Il y a 17 jours
Company DescriptionEurofins 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 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.In 2024, Eurofins generated total revenues of EUR 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years.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.Job DescriptionThe Quality Assurance Associate (Drug Substance) will play a key role in ensuring Eurofins CDMO Alphora Inc.'s compliance with Current Good Manufacturing Practices (cGMP) to ensure the production of safe and efficacious pharmaceutical APIs on behalf of our clients and their patients. This is an excellent opportunity to obtain experience in a pharmaceutical manufacturing setting and to work on projects related to all phases of the pharmaceutical product life cycle. This role will be engaging and challenging for an individual that has a desire to learn and thrives in a high-paced environment with a variety of new projects and unique challenges to overcome.KEY DUTIES AND RESPONSIBILITIES:
  • Quality Oversight
  • Duties include: 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
  • Duties include: Review executed batch records and equipment cleaning records; Batch disposition assignment; Preparation of batch certificates
  • Testing Data Review and Release
  • Duties include: 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
  • Duties include: Support deviation investigations and laboratory investigations; Development of investigation plans; Conducting investigations; Root cause analysis; Risk and impact assessments; CAPA determination
  • QMS Support
  • Duties include: Contribute to QMS development and continuous improvement; Contribute to writing and review of over Standard Operating Procedures (SOPs).
  • Audit Support
  • Duties include: 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
  • Other duties as assigned by the Quality Assurance Manager
QualificationsThe ideal candidate will have:
  • BSc; specialization in Chemistry is preferred
  • 2-5 years of experience
  • An understanding of (cGMP) manufacturing with prior QA and/or laboratory experience being a definite asset
  • Proficiency in Microsoft Office (Word/Excel)
  • 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 InformationAt 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 atWe 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

Eurofins