Bioassay Data Review Specialist

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 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