Bioassay Data Review Specialist

Applies GMP/GLP in all areas of responsibility, as appropriate.

• Perform verification of data and confirm resolution of issues identified
• 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

• 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
• Ability to read, comprehend, and present complex subjects

Minimum Qualifications:

• Bachelor's degree in biology, biochemistry, chemistry, or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
• At least 3 years of related GMP pharmaceutical experience in either an operations or testing role
• Authorization to work in the United States indefinitely without restriction or sponsorship
• Ensure adherence to highest quality and efficiency standards in laboratory operations
• Authorization to work in the United States indefinitely without restriction or sponsorship

• Position is full-time, working Monday-Friday 8:00 a.m.-5:00p.m overtime as needed
• Candidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply.
• Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• #LI-EB1

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.