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QUALITY ASSURANCE OFFICER,Research Compliance

Employer
Boston University
Location
Boston, Massachusetts, United States

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Administrative Jobs
Academic Affairs, Research Staff & Technicians, Institutional & Business Affairs, Assessment, Accreditation & Compliance
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Job Details

QUALITY ASSURANCE OFFICER,Research Compliance

Tracking Code9215 Job 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 supervise protocols dedicated to the development of diagnostics and medical countermeasures for diseases that require BSL-2, BSL-3, or BSL-4 containment. This role will conduct facility audits in selected areas for compliance with federal regulations or as the need arises by sponsor, and maintaining documentation 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.

Main duties as followed:

  • 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 settle 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%)
Required Skills

BA/BS degree in biology or related science. Master's degree preferred.

This position will be instrumental in the development of a QA program specific to the needs of the NEIDL and will be expected to obtain Registered Quality Assurance Professional – GLP credential over time.

Two years of research experience.


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;
    • Academic credentials;
    • Past employment;
    • 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.

Job Location Boston, Massachusetts, United StatesPosition TypeFull-Time/Regular

Organization

The Difference Is Our DNA

What compelled the Bill & Melinda Gates Foundation to award Boston University a grant to fight newborn mortality in Zambia? Why did Martin Luther King, Jr. adopt BU as a place where he could hone his message of justice and equality? And what is the catalyst that prompts 32,557 students from 135 countries to call BU their home every semester? It’s in our DNA: an inherent desire in each of our students, faculty, and staff to vigorously and dauntlessly pursue knowledge—and embrace the unlimited possibilities that come with it.

A Community Unlike Any Other

As you can see below, it takes people, ideas, and a little luck (Boston, you’re our town) to make BU what it is today: one of the most dynamic universities in the world.

Celebrated thinkers: On any given day, students will find themselves mesmerized by Nobel Prize winners, a poet laureate, and the first biomedical engineer ever to receive a MacArthur Foundation “Genius Award,” among others.

Extraordinary teaching: When a classroom starts to percolate with new ideas, it’s because our faculty of scholars and accomplished practitioners know how to ignite students’ imaginations. That’s why we reward our best teachers with BU’s most prestigious honor: The Metcalf Cup and Prize.

Groundbreaking research: With faculty dedicated to a creative, interdisciplinary approach to problem solving, BU has become a leading global research institution—propelled forward by over $350 million a year in sponsored program revenue.

World-class students: Elite students from all 50 states and 135 countries pursue higher education on BU campuses in Boston and at programs in L.A., D.C., and more than 30 other cities on six continents.

A city within a city: Today, 80% of our undergrads live on campus, which could explain the 525 student activity groups alone.

The greatest college town in the world: Boston. ’Nuff said.

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