Laboratory Microbiologist
1 day ago
Data Reviewer Microbiology at Eurofins GSC Poland Sp. z o. o.
We are seeking an experienced Laboratory Microbiologist to join our team in Toronto, Ontario, Canada. As a key member of our Quality Control Laboratory, you will play a critical role in ensuring the accuracy and integrity of our testing results.
Job Description:
The successful candidate will be responsible for reviewing all laboratory related documents, including finished products, bulk, raw material, and stability study products, to ensure compliance with Good Manufacturing Practices (GMP) requirements. You will also be responsible for reviewing data entries in raw data and chromatographic data management systems prior to release of the Certificate of Analysis (CoA) in electronic Laboratory Information Management System (eLIMS).
Key Responsibilities:
- Review laboratory related documents to ensure accuracy and completeness
- Ensure data integrity by verifying data entries in raw data and chromatographic data management systems
- Participate in and/or lead Out of Specifications (OOS) investigations
- Complete Corrective and Preventive Actions (CAPAs)
- Assist laboratory personnel with documentation issues and provide coaching and guidance to Quality Control team members
- 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
- Audit calibration related documents and other QC documents
Required Skills and Qualifications:
To be successful in this role, you will require a Bachelor of Science degree in Microbiology or a related biological science, or equivalent combination of education and experience. You should have over 2 years of experience working in a pharmaceutical regulated laboratory environment or pharmaceutical company. Additionally, you should have knowledge of standard microbiology methods, including but not limited to MLT testing, antimicrobial effectiveness tests, endotoxins, microbial ID (sequencing and biochemical), and antibiotic assays. You should also have sound knowledge of Health Canada and FDA regulations.
Benefits:
Eurofins GSC Poland Sp. z o. o. offers a competitive salary range of $60,000 - $80,000 per year, depending on experience. We also offer excellent language, writing, and communication skills required. Our benefits package includes extended hours or weekend work may be required from time to time. If you are a motivated and detail-oriented individual who is passionate about quality control, we encourage you to apply for this exciting opportunity.
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