Data Reviewer - Cell Bioassay (GMP Lab)

About the position At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations! As a Data Reviewer at Thermo Fisher Scientific you will be an integral part of our research team, driving excellence and innovation. Your contributions will have a direct impact on groundbreaking research and development. In this role you will conduct detailed reviews of a variety of routine and complex analytical analysis experiments that are conducted on pharmaceutical and biopharmaceutical compounds to ensure accuracy and completeness. You will ensure analyses are following validated or experimental analytical procedures, and compare results to methodology, protocol and product specifications, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP). You will review data entered into databases and report and monitor the quality of the laboratory data.

Responsibilities

• Conduct detailed reviews of research data for compliance with analytical methods, client directives, and SOPs.
• Reviews sample results for scientific soundness, completeness, accurate representation of the data, and final reported results.
• Communicates with laboratory staff to proactively maintain the quality of laboratory documentation.
• Collaborate with research teams to determine data collection needs and provide flawless support.
• Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner.
• Escalate significant deficiencies to the project leader or supervisor for assessment.
• Implement data review protocols to strictly adhere to regulatory standards.
• Facilitates in conversations with lab staff on best documentation practices and addressing quality findings.
• Prepare detailed reports summarizing findings and presenting recommendations.
• Support the development of data management strategies to improve research outcomes.
• Identifies and supports process improvement initiatives.
• Performs other duties as assigned.

Requirements

• Bachelor's degree or equivalent experience in a scientific field.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• Proven experience in data review or research roles within a scientific or pharmaceutical environment.
• Demonstrated knowledge of Microbiology skills strongly preferred.
• Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis review independently.
• Ability to collaborate effectively with diverse teams to achieve ambitious goals.
• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP.
• Strong technical knowledge including an understanding of laboratory procedures, methodology, and standards.
• Strong verbal and written communication skills.
• Outstanding attention to detail.
• Ability to balance time and remain focused on work to meet goals.
• Ability to train staff on basic review techniques.
• Ability to independently review laboratory reports and analytical methods.
• Ability to deal with multiple and changing priorities.
• Ability to provide clear and concise feedback and/or documentation of results.
• Ability to work efficiently in a remote capacity.

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