Bioassay Data Review Specialist
Indianapolis, United States
Job Description
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
Qualifications
- 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 related GMP pharmaceutical experience in either 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
Additional Information
Position is Monday- Friday 8:00 am- 5:00 pm. 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
- Authorization to work in the United States indefinitely without restriction or sponsorship
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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Career Focus: Regulatory, Analyst, Bioanalytics
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