Data Reviewer - GMP

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 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.

A Day in the Life:

• Conduct detailed reviews of 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.

Keys to Success:

Education

• Bachelor's degree or equivalent experience in a scientific field.

Experience

• Previous experience that provides 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, Abilities

• Demonstrated knowledge of HPLC, GC, or dissolution testing strongly preferred

• Previous experience with chromatographic data review

• Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis review independently.

• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP

• To demonstrate behaviors which align to the 4i Values of Thermo Fisher

• 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 in a collaborative team environment

• Ability to work efficiently in a remote capacity

Work 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:

• 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.