Quality Assurance Associate - Eurofins CDMO Alphora Inc.

Leids Cytologisch Laboratorium B.V; Oakville; On-site; CAD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Associate to ensure compliance with current good manufacturing practices. This role is crucial for maintaining the quality and safety of pharmaceutical products. The ideal candidate will thrive in a fast-paced environment, engaging with various teams to uphold rigorous standards. With opportunities for professional growth and a commitment to continuous learning, this position offers a dynamic work atmosphere. Join a company recognized for its exceptional workplace culture and contribute to making a difference in the lives of patients through quality assurance in drug manufacturing.

Benefits

Health Coverage

Dental Coverage

Life Insurance

Disability Insurance

RRSP with 3% Company Match

Paid Holidays

Paid Time Off

Qualifications

• 2-5 years of experience in QA or laboratory settings.
• Understanding of cGMP manufacturing processes.

Responsibilities

• Ensure compliance with cGMP and review quality control data.
• Conduct root cause investigations and assist in audits.

Skills

Attention to Detail

Time Management

Project Management

Written Communication

Verbal Communication

Multi-tasking

Interpersonal Skills

Desire for Continuous Learning

Education

Bachelor's Degree in Chemistry

Tools

Microsoft Office

Job description

Quality Assurance Associate - Eurofins CDMO Alphora Inc.

• Full-time

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.

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 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.

The Quality Assurance Associate 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 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:

• Liaise with production, quality control, and analytical services staff
• Review quality control lab data for raw materials, in-process controls, intermediates and APIs for accuracy, completeness and compliance to CGMP or other applicable regulatory standards
• Review executed batch records and production cleaning study reports for accuracy, completeness and compliance to established CGMP or other regulatory standards
• Release intermediate and API batches that satisfy quality requirements
• Review analytical data and protocols for standard qualification, stability, method qualification, and method validation protocols for accuracy, completeness and compliance to GLP or other regulatory standards
• Provide production support including equipment and line clearances
• Review and approve laboratory and batch summary reports
• Review and approve quality documents including but not limited to sampling analysis and labeling forms, deviations/amendments (planned deviations), OOS/OOT/OOC investigations, logbooks, cleaning records, and temperature monitoring data
• Perform oversight of final product packaging operations
• Review and input on Standard Operating Procedures (SOPs)
• Review and feedback on deviation assessments
• Conduct root cause investigations related to deviations, out of specifications, and out of calibrations and evaluate related impact assessments and proposed Corrective Actions/Preventive Actions
• Assist in the development and establishment of suitable Corrective Actions/Preventive Actions (CAPAs) based on investigation outcomes
• Review change controls and QC specifications on a limited basis
• Assist in preparation for internal, 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

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

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.