Bioassay Data Review Specialist

Eurofins USA PSS Insourcing Solutions•Indianapolis, IN

1d•Onsite

About The Position

Eurofins Scientific is an international life sciences company providing analytical testing services. This role involves performing verification of data, cell culture, cell-based bioassays, and surrogate bioassays in a GMP environment. The specialist will anticipate quality events, collaborate with internal and external stakeholders, and contribute to investigations and regulatory inspections.

Requirements

Bachelor’s degree in life science concentration (chemistry, biology, or related fields) and 2 to 4 years of directly related industry experience or a MS degree in a life science concentration (chemistry, biology, or related fields) and up to 2 years of directly related industry experience.
Proficiency in cGMP and FDA regulated clinical services laboratory environment
Strong computer, scientific, and organizational skills
Excellent written and oral communication with attention to detail
Capability to work well on a team and be able to troubleshoot and problem solve in cross functional team setting
Authorization to work in the United States indefinitely without restriction or sponsorship

Responsibilities

Perform verification of data and confirm resolution of issues identified
Perform cell culture, cell-based bioassay, and surrogate bioassays such as ligand-binding ELISA assays in plate-based formats in a GMP environment and other lab tasks for training and as needed.
Anticipate quality events or issues and elevate them to appropriate management attention immediately
Independently engage and collaborate with coworkers, customers, and management within a cGMP environment
Must be able to identify problems and know when to solve proactively and seek advice
Contribute and participate in investigations, as needed
Support regulatory and client inspections, as needed