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 research observations are documented and submitted to the appropriate Study Director/Principal Investigator, and to Management. The QAO will review 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.
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. (25%)
Assists Study Directors/Principal Investigators with performing self-audits in preparation for external audits. Reviews and responds to resulting audit reports ensuring accuracy. (20%)
Reviews and monitors standard operating procedures and processes. (20%)
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. (15%)
Trains in regulatory compliance and audits training files for completeness and compliance (10%)
Other duties as assigned (10%)
BA/BS degree in biology or related science and three years of quality assurance experience. Experience may be substituted for degree requirement.
The National Emerging Infectious Diseases Laboratories (NEIDL) is part of a national network of secure facilities that study infectious diseases - whether they occur naturally or are introduced deliberately through bioterrorism. The NEIDL is dedicated to the development of diagnostics, vaccines and therapeutics to combat emerging and re-emerging infectious diseases. In addition to Bio Safety Level (BSL)-2 and BSL-3 laboratories, the NEIDL houses BSL-4 laboratories that will operate at the highest level of containment. The NEIDL will add to the growing life sciences industry in the region, throughout the Commonwealth of Massachusetts, and across the country.
Individuals seeking affiliation with or employment within the NEIDL may be subject to the following suitability requirements. Failure to meet any of these requirements may result in ineligibility for employment or affiliation:
Criminal Background Check: To be completed in accordance with BU Public Safety guidelines and all federal, state and local laws and regulations.
Basic Background Check: Includes, but is not limited to, verification of:
Social Security Number;
Licenses and credentials;
Sexual Offender Registry Information (SORI) check;
Credit history check;
RMV/DMV driving record, if required.
Medical Clearance Process: includes Research Occupational Health Program (ROHP) evaluation, drug screening, initial psychological screening, and immunization/titer level review completed in accordance with NEIDL Medical Surveillance Policy for all employees working at the NEIDL.
Training and Education: to be completed in accordance with Section 8, Ongoing Personnel Reliability Program, for all employees working at the NEIDL.
Individuals seeking or required to have approval to work with Select Agents will be subject to the following additional requirements:
Department of Justice Criminal Background Check and Fingerprinting: To be completed in accordance with CDC requirements as part of application to have access to Select Agents.
Select Agent Use Approval: to be completed in accordance with all regulations including the requirements of the Boston Public Health Commission (BPHC), Institutional Biosafety Committee (IBC) and the Center for Disease Control (CDC).
Please note, any individual working in the NEIDL facility and granted unescorted access, is subject to
periodic background reviews, including but not limited to: criminal background, credit history, drug screening, and behavioral evaluations;
periodic checks and regular renewals of security credentials, any applicable licenses, and verification of the successful completion of any required training at the facility
Search of person, clothing and effects prior to entry into or egress from NEIDL
When applicable, individuals will be required to maintain all applicable clearances and licenses and to disclose any changes in circumstances that could compromise access to the facility.
Continued employment/ affiliation is contingent upon strict adherence, at all times, to all applicable safety and security rules, procedures, and protocols, as well as required training regimens.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. We are a VEVRAA Federal Contractor.
Internal Number: 9215
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