Quality Assurance Data Review Specialist
5 days ago
We are seeking a highly skilled Quality Assurance Data Review Specialist to join our team at Thermo Fisher Scientific. In this role, you will play a critical part in ensuring the quality and accuracy of our data, driving business growth, and contributing to our mission of enabling our customers to make the world healthier, cleaner, and safer.
Job DescriptionThe Quality Assurance Data Review Specialist will be responsible for:
- Reviewing and verifying data for accuracy and compliance with regulatory requirements;
- Supporting product release activities and ensuring timely delivery of high-quality results;
- Preparing reports and participating in authorship as needed;
- Collaborating with cross-functional teams to drive process improvements and ensure data integrity;
- Providing input on metrics and trending for reporting purposes;
- Maintaining accurate records and documentation;
- Communicating effectively with stakeholders and management on data-related issues;
To be successful in this role, you will need:
- A Bachelor's degree in a lab science such as Chemistry, Biochemistry, Material Science, Immunology, Biology, or Molecular Biology;
- Previous experience in a similar role, preferably with knowledge of US or EU cGMP regulations;
- Familiarity with processes related to batch release, OOS/OOT investigations, reference standards/assay controls, stability studies, LIMS, and raw materials testing;
- Effective communication skills, both verbal and written;
- Laboratory experience;
- Working knowledge of common compendial assays and safety testing for GMP drug products;
We offer a competitive salary of $80,000 - $110,000 per year, depending on experience, plus a range of benefits, including health insurance, 401(k) matching, and opportunities for professional growth and development. Our team is passionate about delivering high-quality results and making a positive impact on the world. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.
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