Pharmaceutical Data Review Scientist

Eurofins•Portage, MI

About The Position

The Pharmaceutical Data Review Scientist ensures clients receive quality data by reviewing laboratory results for accuracy, clarity, and compliance with GMP and/or GLP regulations. The role reviews simple and complex routine and non-routine data across three or more areas, follows departmental, corporate, and client SOPs, and verifies work is performed according to applicable GLP/GMP requirements. The position performs analysis of proteins and associated impurities or raw materials using various analytical techniques. It assesses whether data is compliant and defensible based on industry regulations and methodology, verifies data quality against method, industry, and client requirements, troubleshoots method and instrumentation issues, and produces written reports such as SOPs, OMCs, and client reports.

Requirements

Bachelor's degree in chemistry or another related degree concentration, or equivalent directly related experience.
Authorization to work in the United States indefinitely without restriction or sponsorship.
Strong computer, scientific, and organizational skills.
Excellent oral and written communication skills and attention to detail.
Ability to work independently and as part of a team.
Self-motivation, adaptability, and a positive attitude.
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.

Responsibilities

Review laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations.
Review routine and non-routine data, including simple and complex data across three or more areas, in accordance with departmental, corporate, and client SOPs.
Read and understand analytical procedures and ensure work is performed according to applicable GLP/GMP requirements.
Analyze proteins and impurities or raw materials associated with their production using various analytical techniques.
Determine whether data is compliant and defensible based on industry regulations and methodology.
Verify data quality against method, industry, and client requirements where applicable.
Diagnose problems, solve simple problems, suggest solutions to complex problems, and perform complex calculations.
Troubleshoot method and instrumentation problems.
Use office and instrumentation-specific computer software.
Produce written reports, including SOPs, OMCs, and client reports.