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Boston University QUALITY ASSURANCE OFFICER,Research Compliance in Boston, Massachusetts

QUALITY ASSURANCE OFFICER,Research Compliance



Category

Research

Job Location

Boston, MA

Tracking Code

9215

Salary Grade

Grade 50

Position Type

Full-Time/Regular

Job Description

The National Emerging Infectious Diseases Laboratories (NEIDL) at Boston University is dedicated to the development of diagnostics and medical countermeasures for diseases that require BSL-2, BSL-3, or BSL-4 containment. For some of the pathogens that are studied, FDA licensure will likely require the Animal Rule, to allow for appropriate studies of animals when clinical studies in humans cannot be ethically conducted. All studies subject to this rule must be conducted in accordance with requirements under the good laboratory practices (GLP) To help facilitate these regulated studies, the NEIDL Quality Assurance Officer (QAO) will assess protocols, SOPs and applicable standards of research. Responsibilities include: conducting facility audits and inspections to ensure compliance with federal regulations and sponsor requirements; monitoring study events and facility operations; auditing study records for accuracy; maintaining documentation as required by federal regulations; providing regulatory compliance training; reviewing and developing audit responses to assure that appropriate action is taken to bring a study into compliance; and providing technical expertise to identify actions for resolution of compliance problems.

Required Skills

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;

  • 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.

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