Thermo Fisher Scientific Analytical Data Reviewer in Cincinnati, Ohio

Job Description

Job Title: Analytical Data Reviewer

Location: Cincinnati, OH Pharma Services Group-Oral Solid Dosage

Shift: 2nd Shift Monday-Friday 2p-10pm

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Job Description

Review work in laboratory notebooks for completeness, correctness, and adherence to all SOP’s regarding laboratory notebook procedures and good documentation practices; this includes but is not limited to manual calculation of data, sampling and sample preparation procedures, solution preparations, and work done using both validated and unvalidated test methods; Review chromatographic data (using Empower V3.2) for correctness of integration, identification, and calculation; also ensuring that the correct HPLC/GC conditions were used, including but not limited to sample/column temperature, wavelength, flow rate, scale of peaks, and gradient conditions; Review data collected and results derived from other laboratory instrumentation such as Karl Fischer titrators; IR and UV spectrometers; Review data recorded by observation or other physical testing; Question analyst when errors are suspected, and instruct analyst regarding the correction of these errors; Review results entered into LIMS system, ensuring they match the data contained in the analysis performed and that they fall within established trends and/or specifications; ‘approves’ or ‘not approves’ these data based on Patheon SOP’s regarding stability, finished product, ad-hoc or investigation samples; Notifies Data Review supervisor, or other appropriate supervisor, when data do not fall within established trends and/or specifications, or when unusual or out-of-the-ordinary results are observed.

Requirements:

Minimum 3 years prior laboratory experience is required. Pharmaceutical industry experience is preferred. A good knowledge and understand of analytical chemistry (HPLC, GC, Dissolution) and documentation requirements. Must possess excellent organizational and interpersonal skills, strong oral and written communication skills, and the ability to multi-task and adjust to changing priorities. Applicant must have the ability to work independently and meet strict deadlines. Proficiency in Microsoft Office is preferred. Applicant must be detail oriented.

Education Required:

Associate degree in a scientific discipline is required, with a bachelor’s degree preferred.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.