Quality Assurance Associate

Eurofins CDMO Alphora is looking for a Quality Assurance Associate (Drug Substance) 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 career paths. Job Description The 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. Qualifications The 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 Approximate annual base compensation starts at $65,000 CAD. The actual offer, reflecting the total compensation package plus benefits, will be determined by a number of factors including but not limited to the applicant’s experience, knowledge, skills, and abilities. At Eurofins CDMO Alphora, we leverage artificial intelligence (AI) technology to support our recruitment process, including preliminary screening of applications and resumes. All hiring decisions are made by human reviewers. This posting is for a current vacancy and the successful candidate will start as soon as possible. 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 at www.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. #J-18808-Ljbffr