R&D Scientist II-Reviewer at Thermo Fisher Scientific in Greenville, North Carolina

Job Description:

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. Apply Now