Labs Data Reviewer (GMP, HPLC)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Title: Data Reviewer

Details: Fully remote, full time

Department: Biopharmaceutical

This is a fully remote role supporting our GMP Lab in Middleton, Wisconsin. 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:

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). 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.

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.

Keys to Success:

Education

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

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 experience of HPLC data review and Empower strongly preferred

• Previous experience in GMP regulated laboratory environment preferred strongly preferred

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

• Thorough knowledge of chromatography.

• 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

• Strong attention to detail

• Ability to balance time and remain fo