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Boston University
Boston, MA, United States
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. Add
Job Source: Boston UniversitySRA International
Cambridge, MA, United States
Founded in 1890, the Faculty of Arts and Sciences (FAS) is the largest division of Harvard University. FAS is dedicated to being at the forefront of teaching and learning and fostering cutting-edge research and discovery. FAS is redefining liberal arts education for the 21st century and is committed to making a Harvard education accessible to stude
Job Source: SRA InternationalNAHMA - The National Affordable Housing Management Association
Cambridge, MA, United States
Job Summary Working under the general supervision of the Chief Research Compliance Officer, the incumbent ensures that researchers comply with regulatory and ethical laws, regulations and procedures by working with various stakeholders in the management and development of sponsored program policies and procedures related to research compliance; pro
Job Source: NAHMA - The National Affordable Housing Management AssociationHarvard University
Cambridge, MA, United States
Basic Qualifications Candidates MUST meet the following basic qualifications in order to be considered for this role: A Bachelor's Degree and a minimum of seven years of relevant experience. Education may count toward years of experience. Additional Qualifications and Skills Advanced degree preferred, in a scientific/technical field, with knowl
Job Source: Harvard UniversityPhaidon International
Billerica, MA, United States
EPM are looking for two Quality Assurance Specialists with extensive experience in compliance responsibilities. The specialist in question will be expected to be On-Site 5 days a week, this would be a non-negotiable! The work would involve experience working with systems such as Trackwise, Veeva or QMS. Duties and Responsibilities: Investigates co
Job Source: Phaidon InternationalDana-Farber Cancer Institute
Boston, MA, United States
Job ID: 38200 Location: 10 Brookline Place West, Brookline, MA 02445 Category: Research Administration Employment Type: Full time Work Location: Remote: occasional time on campus Overview This position's work location is fully remote with the expectation of being onsite 1 day per week.The selected candidate may only work remotely from a
Job Source: Dana-Farber Cancer InstituteDana-Farber Cancer Institute
Brookline, MA, United States
Overview This position's work location is fully remote with the expectation of being onsite 1 day per week. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI). The Assistant Director, Research Compliance will work under the oversight of Dana-Farber Cancer Institute's (DFCI's, Institute's) Research Compli
Job Source: Dana-Farber Cancer InstitutePhilips North America
Cambridge, MA, United States
Job TitleCompliance Officer Quality Agreements Job Description In this role you will be responsible for: Supports improvements in the purchasing control requirements to suppliers through the review and alignment of the Supplier Quality Agreements Ensures improvement in the integration and validation of purchasing procedures with supporting IT an
Job Source: Philips North AmericaBoston, MA, United States
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 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.
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Email Alert for QUALITY ASSURANCE OFFICER, Research Compliance jobs in Boston, MA, United States
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