R&D Scientist II-Reviewer

at  Thermo Fisher Scientific

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.

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

• 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