SierTek Ltd. is seeking a Laboratory Compliance Manager to support an opportunity at the Wright Patterson AFB, OH (On-Site).
The 711th Human Performance Wing (711 HPW), headquartered at Wright-Patterson Air Force Base in Ohio, is the first human-centric warfare wing to consolidate human performance research, education, and consultation under a single organization. Established under the Air Force Research Laboratory, the 711 HPW is comprised of the Airman Systems Directorate (RH) and the United States Air Force School of Aerospace Medicine (USAFSAM). The Wing delivers unparalleled capability to the Air Force through a combination of world class infrastructure and expertise of its diverse workforce of military, civilian and contractor personnel encompassing 75 occupational specialties including science and engineering, occupational health and safety, medical professions, technicians, educators, and business operations and support. The Laboratory Compliance Manager shall ensure the Applied Technologies and Genomics Division (PHT) laboratory is in compliance with Institutional Biosafety Committee (IBC), Federal Select Agent (FSA) regs/guidelines, and/or other regulatory body. In addition, provide consultation, as needed, to other Departmental (PH) laboratories.
Essential Job Functions
· Ensure the Applied Technologies and Genomics Division (PHT) laboratory is in compliance with Institutional Biosafety Committee (IBC), Federal Select Agent (FSA) regs/guidelines, and/or other regulatory body. In addition, provide consultation, as needed, to other Departmental (PH) laboratories.
· Conduct internal inspections using pre-inspection checklists for Biosafety Level (BSL) 2 /BSL3 laboratories with DoD oversite, maintain lab checklists, and report adverse findings to the IBC as well as to PHT Division and PH Departmental leadership.
· Coordinate with investigators and/or government scientists to ensure IBC, IRB, and FSA protocols are current. Additionally, assist divisional or departmental staff in the preparation, coordination, and submission of new protocols.
· Work with, train, and collaborate with Divisional or Departmental staff on various projects and initiatives.
· Work with laboratory personnel to document standard operating procedures and work with laboratory management to ensure new policies and or guidelines are documented.
· Support the laboratory with other tasks as required to ensure proper function of the laboratory, including but not limited to communal solid waste disposal, and general laboratory maintenance procedures.
· Abide by all Federal, State and USAFSAM directives concerning the confidentiality of records, as embodied in federal statutes including the Privacy Act of 1974 and Health Information Portability Accountability ACT (HIPAA).
Minimum Position Requirements
· Possess a minimum of a master’s degree in a biological, biomedical, biochemistry or related field.
· Expertise in biosecurity and biosafety concepts with at least 5-7 years of practical, demonstrated experience in those fields.
· Demonstrated knowledge and experience in one or more technical areas related to biosecurity, including but not limited to: laboratory biosecurity; physical security; personnel reliability programs; sample transport security; public health surveillance; infection prevention and control; laboratory systems strengthening and bio risk management; laboratory biosafety.
· Experience working with institutional biosafety committees in addition to familiarity with regulatory activities across the Department of Defense.
· Experience in performing the roles and responsibilities of a biosafety officer.
· Possess excellent organizational, management, and communications skills including writing ability.
· Possess a documented history of scientific writing as evidenced in technical reports or presentations. Additionally, the candidate must possess the ability to convey those details to staff in the form of training material, consultations, and or presentations.
· Sign a Non-Disclosure Agreement in place. This is necessary to mitigate transfer of any confidential, proprietary and/or sensitive information while in this position.
· Ability to successfully pass a Tier I background check.
Highly Desired Qualifications.
· Preferred experience and knowledge of biosecurity regulatory frameworks (such as the US Select Agents regulations).
· Demonstrated knowledge of virology, practical experience in safe handling of viruses, viral production, and storage of viruses is a plus.
· Possess knowledge and experience interpreting clinical laboratory regulations including those outlined in the Clinical Laboratory Improvement Act (CLIA).
· Possess knowledge and experience navigating IRB protocols involving human subjects research and interpreting associated regulations as described in the Title 45, Code of Federal Regulations (CFR), Part 46, “Protection of Human Subjects”.
SierTeK is an equal opportunity employer and values diversity. Employment is decided based on qualifications, merit, and business need. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, gender identity and sexual orientation.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfer, leaves of absence, compensation, and training.
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