Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

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:The Data Reviewer performs 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. Ensures 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).A day in the Life:Evaluates laboratory 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.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.Facilitates in conversations with lab staff on best documentation practices and addressing quality findings.Advocates for quality and review process changes.Identifies and supports process improvement initiatives. Performs other duties as assigned.Reviews data entered into databases and reports and monitors the quality of the laboratory data. Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis review independently. Keys to Success: EducationBachelor's degree or equivalent and relevant formal academic / vocational qualificationExperiencePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience. ​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, AbilitiesThorough knowledge of SOPs and Federal Regulations to include GLP and GMPThorough knowledge of chromatography may be required.To demonstrate behaviours which align to the 4i Values of Thermo FisherStrong technical knowledge including an understanding of laboratory procedures, methodology, and standardsStrong verbal and written communication skillsStrong attention to detailAbility to balance time and remain focused on work to meet goalsAbility to train staff on basic review techniquesAbility to independently review laboratory reports and analytical methodsAbility to deal with multiple and changing prioritiesAbility to provide clear and concise feedback and/or documentation of resultsAbility to work in a collaborative team environmentAbility to work efficiently in a remote capacityWork Environment Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:Remote work environment should remain free of outside distractions. Occasional drives to site locations may be required.Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary and/or standing for typical working hours.Able to lift and move objects up to 25 pounds.Able to work in non-traditional work environments.Able to use and learn standard office equipment and technology with proficiency.May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!