About this role
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 OversightDuties 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 ReleaseDuties include: Review executed batch records and equipment cleaning records; Batch disposition assignment; Preparation of batch certificatesTesting Data Review and ReleaseDuties 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 InvestigationsDuties include: Support deviation investigations and laboratory investigations; Development of investigation plans; Conducting investigations; Root cause analysis; Risk and impact assessments; CAPA determinationQMS SupportDuties include: Contribute to QMS development and continuous improvement; Contribute to writing and review of over Standard Operating Procedures (SOPs). Audit SupportDuties 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 activitiesParticipate in opportunities to develop knowledge of CGMP and business operationsOther duties as assigned by the Quality Assurance Manager The ideal candidate will have:
BSc; specialization in Chemistry is preferred2-5 years of experienceAn understanding of (cGMP) manufacturing with prior QA and/or laboratory experience being a definite assetProficiency in Microsoft Office (Word/Excel)Strong written and verbal skills are a priorityA proficiency for multi-taskingExcellent interpersonal skillsGood time management and project management skillsA focus on attention to detailBe goal orientated and results drivenA desire to learn and for continuous developmentThe approximate annual base compensation for this position starts at $65,000 CAD. The actual offer, reflecting the total compensation package plus benefits, will be determined by a number of factors which include but are not limited to the applicant’s experience, knowledge, skills, and abilities.
Disclaimer: Salary information posted on sites other than the official careers page does not reflect the organization’s compensation and may represent estimated ranges provided by third-party job boards. The organization offers competitive wages and a comprehensive total rewards package, which will be discussed during the interview process.
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.
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 www.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 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.
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