Data Reviewer Microbiology

2 weeks ago

Toronto, Canada Eurofins Canada BioPharma 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._**
- Review of 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 as per the agreed timelines.
- Review accuracy of data entries in raw data and chromatographic data management systems prior to release of the CoA in eLIMS.
- To ensure data integrity is maintained in all the process.
- Complete all training assignments and maintain personal training records.
- Participate in and/or lead Out of specifications Investigations OOS.
- Complete Corrective and Preventive Actions (CAPA’s).
- Participate in Internal, Customer and Regulatory Audits.
- Assist laboratory personnel with documentation issues and provides coaching and guidance to Quality Control team.
- Provide support for Regulatory Inspections.
- Identifies and implements key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements.
- Notifies department supervisor/manager regarding omissions, incomplete testing results or other irregularities.
- Ensures the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the scientists/chemists during the testing.
- May be essential to perform alternating or rotating shift work (as required).
- Follows up with analysts/technicians to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices standards.
- Audits calibration related documents and other QC documents;
- Inputs 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 (eg. LIMS) and other lab equipment to be able to perform audit trail 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 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**

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.

NO AGENCIES, CALLS OR EMAILS PLEASE

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