FSP - Data Reviewer

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description This is a fully remote role supporting our customer’s site in Greenfield, IN. We welcome applicants from all locations within the US.   Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. 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. Discover Impactful Work: As a Data Reviewer, your role will be to perform review of a variety of routine and complex analytical analysis experiments that are conducted on pharmaceutical and biopharmaceutical compounds with various formulations and/or biological matrices. 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). Review data entered into databases and reports and monitors the quality of the laboratory data. Possess a thorough understanding of laboratory procedures and can reliably conduct complex analysis review independently.   What You’ll Do: Evaluate laboratory data for compliance with analytical methods, client directives, and SOPs. Review sample results for scientific soundness, completeness, accurate representation of the data, and final reported results. Communicate with laboratory staff to proactively maintain the quality of laboratory documentation. Deliver 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. Facilitate conversations with lab staff on best documentation practices and addressing quality findings. Advocate for quality and review process changes. Identify and support process improvement initiatives. Perform other duties as assigned. Education and Experience: • Bachelor's degree (Life Sciences degree preferred) or equivalent and relevant formal academic / vocational qualification • Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 2+ years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP Thorough knowledge of chromatography may be required. To demonstrate behaviours which align to the 4i Values of Thermo Fisher Strong technical knowledge including an understanding of laboratory procedures, methodology, and