QUALITY ASSURANCE OFFICER, Research Compliance

Tracking Code23500588220424Job Description

The Office of Research Compliance is in need of a Quality Assurance Officer (QAO) for the National Emerging Infectious Diseases Laboratories (NEIDL) at Boston University. The QAO will assess and monitor protocols dedicated to the development of diagnostics and medical countermeasures for diseases that require BSL-2, BSL-3, or BSL-4 containment. Additional responsibilities include conducting facility audits in selected areas for compliance with federal regulations or as required by sponsor, and maintaining documentation as required by regulatory guidelines. The QAO assures that audit observations are documented and submitted to the appropriate Study Director/Principal Investigator, and to Management. The QAO will review audit responses to assure that appropriate action is taken to bring a study into compliance and will provide technical expertise to identify actions for resolution of compliance problems.

The Opportunity

• Join a fast paced work environment providing service across Biosafety Levels 2, 3 and 4
• Collaboratively work with other departments within the NEIDL.

• Have the benefits of working within a large university, which includes generous medical, dental, retirement, and tuition remission benefits. See link to tuition remission information. https://www.bu.edu/hr/learningbu/tuition-remission/

Job Responsibilities

• Assists Study Directors/Principal Investigators in the preparation and review of Quality Assurance section of proposals. Monitors ongoing non-clinical laboratory studies to ensure compliance to protocols, quality plans, standard operating procedures, and regulatory requirements
• Assists Study Directors/Principal Investigators with performing self-audits in preparation for external audits, as well as working with study teams to facilitate the conduct of external sponsor and regulatory agency audits and inspections. Reviews and responds to resulting audit reports ensuring accuracy.
• Reviews and monitors standard operating procedures and processes
• Conducts audits of facilities, procedures, and data to determine compliance with regulatory requirements, maintains archives of same, as required by sponsors that include Biomedical Advanced Research and Development Authority (BARDA), National Institutes of Health (NIH) etc.
• Trains staff in regulatory compliance and audits training files for completeness and compliance

Required Skills

• B.A./B.S. in a related field
• 8 years of related experience in quality assurance and/or research laboratory work
• Excellent communicator
• Proven ability to work with a wide range of staff levels
• Successful completion of a pre-placement physical.

Preferred Experience

• Work within a research laboratory environment involving infectious diseases research
• Experience in compliance inspections with external regulators.

Please note all newly hired staff and faculty will need to be in compliance with Boston University’s COVID-19 Vaccination and Booster Requirement within 30 days of date of hire. You must upload your vaccine documentation or request a medical or religious exemption (instructions). For further information on the University’s response to COVID-19, please visit the COVID-19 Resources site.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, physical or mental disability, sexual orientation, gender identity, genetic information, military service, pregnancy or pregnancy-related condition, or because of marital, parental, or veteran status. We are a VEVRAA Federal Contractor.

Job LocationBOSTON, Massachusetts, United StatesPosition TypeFull-Time/Regular