Data Reviewer Microbiology (Fixed-Term)- Eurofins BioPharma Product Testing Toronto, Inc.

Eurofins Humangenetik & Pränatal-Medizin; Old Toronto; On-site; CAD 60,000 - 90,000; Full time

Job summary

Join a forward-thinking company that stands at the forefront of life sciences and analytical testing services. This full-time role offers an exciting opportunity to contribute to quality control in a dynamic laboratory environment. You will be responsible for reviewing critical laboratory documents, ensuring compliance with GMP standards, and maintaining data integrity. Your expertise in microbiology and quality assurance will play a vital role in supporting regulatory inspections and enhancing laboratory processes. If you thrive in a fast-paced setting and are passionate about making a difference in the life sciences sector, this position is perfect for you!

Benefits

International Recognition as a Great Place to Work

Opportunities for Professional Development

Supportive Work Environment

Qualifications

• Bachelor's degree in Microbiology or related field required.
• 2+ years in a pharmaceutical regulated laboratory environment.

Responsibilities

• Review laboratory documents per GMP requirements.
• Ensure data integrity and assist with audits and investigations.

Skills

Microbiology Methods

Quality Control

Data Integrity

Regulatory Compliance

Communication Skills

Education

Bachelor of Science

Equivalent Experience in Pharmaceutical QC

Tools

LIMS

Chromatographic Data Management Systems

Job description

• Full-time

Company Description

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. 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 2023, Eurofins generated total revenues of EUR 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

• Review all laboratory-related documents in the Quality Control Laboratory e.g.: finished products, bulk, raw material and stability study products as per GMP requirements in a timely manner.
• Review accuracy of data entries in raw data and chromatographic data management systems prior to the release of the CoA in eLIMS.
• Ensure data integrity is maintained in all processes.
• Complete all training assignments and maintain personal training records.
• Participate in and/or lead Out of Specifications Investigations (OOS).
• Complete Corrective and Preventive Actions (CAPAs).
• Participate in Internal, Customer and Regulatory Audits.
• Assist laboratory personnel with documentation issues and provide coaching and guidance to the Quality Control team.
• Provide support for Regulatory Inspections.
• Identify and implement key process improvements to enhance systems, gain site efficiencies and elevate GMP requirements.
• Notify department supervisor/manager regarding omissions, incomplete testing results or other irregularities.
• Ensure that test methods, protocols and Standard Operating Procedures (SOPs) are followed by scientists/chemists during testing.
• May be essential to perform alternating or rotating shift work as required.
• Follow up with analysts/technicians to ensure that all necessary corrections are made in accordance with Good Manufacturing Practices standards.
• Audit calibration-related documents and other QC documents.
• Input data for trending departmental KPIs.

Qualifications

• Education: Bachelor of Science degree (or equivalent combination of education and experience such as College with 5-10 years of pharmaceutical QC testing/records review experience) in Microbiology or related biological science or equivalent in job experience.
• Over 2 years of experience working in a pharmaceutical regulated laboratory environment or Pharmaceutical Company.
• Ability to work with electronic systems (e.g., LIMS) and other lab equipment to perform audit trails of testing records.
• Knowledge of standard microbiology methods including but not limited to MLT testing, antimicrobial effectiveness tests, endotoxins, microbial ID (sequencing and biochemical) and antibiotic assays.
• Sound knowledge of Health Canada and FDA regulations.
• Works well under pressure.
• Quality Assurance/Quality Control audit background in the pharmaceutical industry is an asset.
• Extended hours or weekend work may be required from time to time.
• Excellent language, writing and communication skills required.

Additional Information

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.