Job Information
ThermoFisher Scientific R&D Scientist II-Reviewer in Greenville, North Carolina
Work Schedule
First Shift (Days)
Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
The R&D Scientist II-Reviewer independently performs complex data reviews in support of validations, development testing, protocols and reports. In addition, the reviewer is to provide vital support of in-process, release and stability testing. The reviewer functions are also dedicated to laboratory Integrity Compliance activities as mandated by corporate standards.
Requirements/Responsibilities:
Perform cGMP analytical data review for various techniques to ensure adherence to established procedures, analytical standards, GVLs and SOPs
Determine if reported data meets specification or standards
Verify that data is accurately entered into its designated software systems for approval (LIMS/SLIM)
Trend data where applicable to ensure requirements are met
Demonstrate advanced knowledge and experience in Empower
Demonstrate advanced knowledge in HPLC, UV
Demonstrate knowledge in method validation
Strong attention to detail and organizational skills
Ensure that all laboratory testing and activities are carried out in compliance with regulations, ICH guidelines, and USP/EP Pharmacopeia
Assist in trainings as an SME
Communicate with Project Lead concerning project status and/or concerns
Demonstrate ability to work as a great teammate and in a fast-paced environment
Must be able to set project priorities and time management in order to enhance efficiency
Actively participate in ongoing trainings and seek out opportunities to increase your contributions for development of skills and responsibilities
Works closely with analyst to complete corrections
Education:
(Associates degree required -bachelor’s degree preferred) All degrees must be from a scientific field
Associates degree with 5 years of pharmaceutical experience and at least 3 years of reviewing data for cGMP compliance.
Bachelor’s degree with 3-5 years of pharmaceutical experience and at least 2 years of reviewing data for cGMP compliance.
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.