R&D Scientist Ii-Reviewer

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.