Bioassay Data Review Specialist
About The Position
Eurofins Scientific is an international life sciences company providing a unique range of analytical testing services. The Bioassay Data Review Specialist will apply GMP/GLP in all areas of responsibility. This role involves performing verification of data and confirming resolution of issues identified. The specialist will anticipate quality events or issues and elevate them to appropriate management attention immediately. They will independently engage and collaborate with coworkers, customers, and management within a cGMP environment. The role requires the ability to identify problems, know when to solve proactively, and seek advice. The specialist will contribute and participate in investigations, as needed, and support regulatory and client inspections, as needed.
Requirements
- 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
- 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
Responsibilities
- 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
- Ensure adherence to highest quality and efficiency standards in laboratory operations
Benefits
- Comprehensive medical coverage
- Dental options
- Vision options
- Life insurance
- Disability insurance
- 401(k) with company match
- Paid vacation
- Paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
