Regulatory Compliance Specialist - Hybrid/Remote t

at The Jackson Laboratory in Bar Harbor, Maine, United States

Job Description

The Regulatory Compliance Specialist works under the supervision of the Manager, Regulatory Compliance, Animal Welfare Compliance and Quality Systems Development. The incumbent will provide professional support to the Animal Welfare and Compliance (AWC) Office, the Institutional Animal Care and Use Committees (IACUC), the Institutional Biosafety Committee (IBC), and Comparative Medicine and Quality (CMQ) and is primarily responsible for the management of a caseload of various applications. Responsibilities include, but are not limited to:

* Conducting scheduled and unscheduled inspections of laboratories, animal rooms, and support areas to ensure compliance with state and federal guidelines, approved protocols, and laboratory policies and procedures; this includes the semi-annual facility inspection process and follow up on general research compliance and welfare concerns. The incumbent will identify compliance risks and develop a basis for observations based upon documented company policies and procedures.

* Working with senior management on complex compliance issues to facilitate acceptable corrective actions and to ensure the actions achieve the desired results. The incumbent is responsible for maintaining and monitoring all documented compliance concerns as well as generating correspondence associated with compliance concerns.

* Scheduling and facilitating the semi-annual program review as required by PHS Policy for the Humane Care and Use of Animals (PHS Policy).

* Cross training of assigned tasks across other regulatory oversight committees and/or JAX locations.

In this senior role, the incumbent will demonstrate sound judgment, as well as analytical, communication, organizational, and time management skills. The assigned job responsibilities require a firm foundation in the guidance and regulations that govern humane care and use of laboratory animals.

2/3 days per week Hybrid/Remote to Ellsworth and Bar Harbor, ME

Inspections and Program Review: Incumbent will organize and lead the
inspections within the required time-frames. Works directly with investigators
and departmental managers to determine appropriate corrective actions and
schedules for any noted facility or program deficiencies. Responsible for
monitoring the progress of corrections and intervening as necessary when
corrections are not progressing as anticipated. Generates facility work orders
directly in the Service Now system as needed in response to items identified
during facility inspections. Shall facilitate the semi-annual program review as
required by the PHS Policy. Responsible for monitoring the corrective action
process and intervening as necessary when corrections are not progressing as

Post Approval Monitoring/ Compliance Assessment: Responsible for
maintaining and monitoring all documented compliance concerns entered into
the 'PAMCompliance' shared drive. This system ensures a continued historical
documentation by individual investigators of all compliance concerns, corrective actions, and associated documentation collected to date. General compliance inspections: Perform scheduled and unscheduled compliance oversight visits in all animal rooms, operational areas, and investigator laboratories where animal or rsNA work is performed or supported. The purpose of these inspections is to assess compliance with Standard Operating Procedures (SOPs), approved protocols/registrations, and JAX policies. Incumbent will create reports and present findings to the appropriate investigative departments. Review Staff Request forms in conjunction with approved Animal Use Summaries to ensure various requests are appropriately described within approved protocols. Review approved grant awards in conjunction with approved protocols and registrations to ensure work is appropriately described and approved within the documents. Is a standing member of the Institutional Animal Care and Use Committee (IACUC); performs summary/amendment reviews as well as participates in all regularly scheduled and special meetings. Incumbent may be asked to facilitate, or serve on, specially formed subcommittees on a variety of topics related to animal welfare, rsNA use, and/or regulatory compliance.

Grant Compliance and Assessment: Responsible for monitoring all animal related grant documentation to ensure the information is cohesive with all approved AWC documentation. In instances where additional information is needed, the incumbent will work with the Office of Sponsored Programs (OSP) and the investigator to ensure compliance.

Welfare Investigations: Responsible for conducting animal welfare
investigations as needed. Provides a summary report of findings and follows up on corrective actions to... For full info follow application link.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

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Job Posting: 909334

Posted On: Mar 28, 2023

Updated On: Apr 20, 2023

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