Shearwater Systems, LLC is a Mission Support Services and Facility Support Services company providing support to government and commercial entities. Shearwater is an 8(a) Program certified, Alaska Native Corporation (ANC)-owned, Small Disadvantaged Business (SDB). We are a subsidiary of Three Saints Bay, LLC, which is owned by Old Harbor Native Corporation. Our Corporate Headquarters is located in Anchorage, AK and our Operational Office is in Manassas, VA.
The scope of this contract entails operation, management, and support of FDA onsite document, records and information management related activities. Support encompasses records lifecycle activities, quality control, DCC management, storage services, onsite DCC scanning, training, metadata management, and records management.
Records include regulatory, administrative, and program materials that support the agency’s business functions. Business functions of the FDA pertain to human and animal pharmaceutical and biological drugs, scientific research, food safety, medical devices, and public health issues.
- Task order level project management to effectively manage tasks, monitor task order performance, manage contractor staff and provide subcontractor management; and establish notification mechanisms for acceptance by the government.
- Prepare a Task Order Management Plan (TOMP) describing the technical approach, organizational resources and management controls, to include QCP as required in individual task orders, to be employed to meet the cost, performance and schedule requirements throughout task order execution.
To successfully conduct task order management the contractor task order manager shall:
- Comply with reporting requirements as stipulated in the task orders.
- Follow escalation procedures for problems, issues, and recommendations as specified in individual task orders.
- Participate in FDA’s program/project reviews, management briefings, stakeholder presentations, and cross‐agency information exchanges, in order to provide expert counsel to DCC staff and document lessons learned as directed by the TO COR.
- Ensure proper exit criteria are followed when contractor employees leave projects.
- Please note that this may be subject to change based on individual Task Order requirement.
- Develop transition‐in and out plans for individual task orders issued against this IDIQ contract vehicle.
- Assist in implementing new guidance and / or mandates during the life of the contract.
- Assist with implementing and maintaining internal supplemental Standard Operating Procedures and Quality Controls to ensure agency‐wide adherence to new policies.
- Ability to pass a Federal Background Investigation.
- Bachelor’s degree in a business administration, public administration, or a field closely related to records management.
- Demonstrated abilities in the management of similar records projects for a minimum of eight (8) years, preferably in a contract environment.
- Previous experience must contain a significant amount of client customer service.
- Demonstrated the ability to manage a regulatory document and records management effort including a staff of specialty and line managers.
- Knowledge of contemporary project management tools and will have a command of the core principles of effective management, including effective delegation, ownership, responsibility development and tracking.
- Ability to plan, integrate, and manage life cycle regulatory document operations involving document processing in high volume automated and manual operations and scientific data abstraction operations.
- Ability to effectively communicate with the COR, FDA management, user organizations, and technical staff.
- Extensive knowledge of life‐cycle Records Management processes including experience developing and implementing file plans, records inventories and records disposition schedules.
VEVRAA Federal Contractor
Three Saints Bay, LLC and its subsidiaries offer a diverse, team-oriented working environment and the opportunity to work with exceptional dedicated industry professionals. We offer our employees a comprehensive benefits package and the opportunity to take part in exciting projects with government and commercial clients, both domestic and international.
We are an EEO/AA employer. We invite resumes from all interested parties without regard to race, color, religion, creed, gender, national origin, age, genetic information, marital or veteran status, disability, or any other category protected by federal, state, or local law.