R&D Scientist II-Reviewer

4 weeks ago


Greenville, South Carolina, United States Thermo Fisher Scientific Full time

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.



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