Attachment F-Labor Category Descriptions.pdf

Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ Recompete Request for Proposal (RFP) No. 75F40126R00009

Attachment F: Labor Category Descriptions

Attachment F Labor Category Descriptions

The staff for each task order will include positions selected from the following labor categories. Not all categories may be used for each task order. By mutual agreement by the Contractor and the Government, additional labor categories may be added at a later date to the schedule.

Program (Contract) Manager: The Program Manager must possess a bachelor's degree in a technical, business, information/records management discipline and have a minimum of 10 years of project management experience in a federal environment. The Program Manager must have demonstrated knowledge of contract analysis, contract compliance, document processing, database management, and records management including familiarity with the Federal Acquisition Regulation (FAR) and agency-specific contracting requirements. The Program Manager must have demonstrated experience managing a workforce of 60 or more employees across multiple task orders and locations, including directing, managing, and coordinating resources and staff. They must have a proven track record of preparing and delivering formal written reports, status updates, and other contract deliverables in a federal contract environment. They must be able to to effectively communicate with the FDA CORs/TOPM and ensure timely response for all communications and deliverables across all task orders.

Senior Technical Information Specialist/Senior Task Leader: The Senior Technical Information Specialist must have a high school diploma with 5 years of experience in the tasks outlined in the FIRF Statement of Work and Premarket and Postmarket Services Task Order. They must be proficient in reading, analyzing, classifying, and interpreting regulatory submissions. This individual must be able to implement SOPs and train staff in their use.

They must have experience with scientific regulatory documents, and excellent speaking, writing, and customer service skills. In addition, the Senior Technical Information Specialist must have an in-depth background with computer use, including a working knowledge of the standard Microsoft suite of products. They must have experience in areas such as quality control, overseeing document tracking databases, inventorying records, scanning, and micrographics.

Quality Assurance Analyst (QAA): The Quality Assurance Analyst must have a high school diploma and 4 years of hands-on quality assurance experience in the tasks outlined in the Premarket & Postmarket Services Statement of Work. They must have excellent computer and communication skills and customer service experience in a medical device document control environment.

Project Manager: The Project Manager must possess a bachelor's degree and/or 8 years of experience managing similar records projects in a federal environment. The Project Manager must be able 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. The individual must have an extensive knowledge of life-cycle Records Management processes including experience developing and implementing file plans, records inventories and records disposition schedules. The project manager must have excellent communication and customer service skills to effectively communicate with the COR, FDA management, user organizations, and technical staff. The Project Manager must have a proven track record of preparing and delivering formal written reports, status updates, and other contractual deliverables in a federal contract environment.

Supervisor: The Supervisor must have a high school diploma and 4 years of progressively more responsible managerial experience in an information and records management environment. The individual must have experience developing and maintaining Standard Operating Procedures (SOPs). They must be able to plan and

Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ Recompete Request for Proposal (RFP) No. 75F40126R00009

Attachment F: Labor Category Descriptions schedule production and resources to ensure turnaround requirements and deliverables are met. They must have the ability to effectively communicate with FDA user organizations and technical staff and be able to serve as the project alternate to the Project Manager. They must have a general knowledge of life-cycle records management including the use of file plans, records inventories, and records retention schedules. The Supervisor must be able to manage the employees and workloads for document room activities including, but not limited to, scanning, document processing, data entry, and paper and electronic file management.

Subject Matter Expert (SME): The Subject Matter Expert must have a high school diploma and 3 years of experience in the tasks outlined in the Premarket and Post Market Task order and FIRF Statement of work. The QAS must have excellent computer skills to be able to respond quickly and handle documents within the timeframes specified by FDA. The SME must have excellent communication skills to be able to respond to inquiries within timeframes specified. They must have a proven track record of providing a high level of customer service to stakeholders seeking assistance from FDA.

Technical Information Specialist: The Technical Information Specialist must have a high school diploma and 3 years of experience in an FDA records management environment. The individual must have experience with reading and classifying regulatory documents. They must have excellent oral and written communication skills, excellent customer service skills, and experience in working areas such as document tracking databases, scanning, and micrographics.

Driver Courier: The Courier must possess a high school diploma and a valid driver’s license from the state of legal residence and at least 2 years’ good driving record. In addition, the Courier must be able to lift 40 lbs.

Records Management Specialist I: The Records Management Specialist I must have a high school diploma and 1 year of experience in the tasks outlined in the Premarket & Postmarket Tracking Statement of Work. This individual must be able to work in both a paper and electronic production environment. They must be able to lift 35 lbs., bend and stretch to reach files, and push a fully loaded mail cart. Records Management Technicians must have demonstrated experience with data entry, barcoding, filing, scanning, mail handling, customer service, and document processing in a medical device document control environment.

Program System Analyst: The Program System Analyst must have a bachelor’s degree in computer science, information technology, information systems or a closely related field. The Program System Analyst must have a minimum of 5 years' experience in database management or systems analysis. They must have experience with database management systems, the ability to perform database queries and troubleshooting and the ability to restore database functionality in the event of a malfunction or crash. The program system analyst must have familiarity with federal data management requirements, including data security and privacy standards relevant to a federal environment. They must also be able to prepare and deliver written status reports and technical documentation, and to communicate effectively with technical and non-technical staff.

Quality Assurance Specialist (QAS): The Quality Assurance Specialist must have a high school diploma and 2 years of hands-on experience in the tasks outlined in the FIRF Statement of Work. The QAS must have excellent computer and communication skills. The QAS must have excellent communication skills and demonstrated customer service experience in a medical device document control environment.