Laboratory Records & Administrative Specialist
About the role
The Laboratory Records & Administrative Specialist supports the U.S. Food and Drug Administration (FDA) Office of Regulatory Testing and Surveillance (ORTS) at one of eight Human and Animal Food Laboratory locations across the United States. The position plays a key role in ensuring the integrity and accessibility of analytical laboratory records.
Responsibilities
- Prepare, scan, and convert analytical worksheet packages into OCR-enabled PDF format, ensuring all pages are present, properly ordered, and optimized to meet FDA’s file size requirements (≤85 MB).
- Login into LIMS to upload completed worksheet packages and send email notifications to the corresponding compliance teams.
- Organize and maintain electronic repositories of scanned documents, creating backup copies and performing routine cleanup and compression of electronic files.
- Archive and organize hard copies of worksheet packages — boxing, labeling, barcoding, and indexing records in accordance with FDA’s records retention schedule.
- Retrieve archived hard copy and electronic records upon request by FDA officers.
- Cook up and coordinate and witness onsite records destruction (shredding) in accordance with FDA’s retention schedule, maintaining a destruction log.
- Provide administrative support including scheduling meetings via Microsoft Outlook, recording meeting minutes and action items, and preparing travel estimates.
- Support laboratory operations using Microsoft Office (Word, Excel, PowerPoint, Outlook), SharePoint, Visio, and Project.
- Aid in equipment and chemical inventory, data entry into laboratory systems, mail handling, and supply logistics.
- Complete all mandatory FDA training, including annual Computer Security Awareness, LIMS, QMiS, Privacy and Records Management, and driver training as required.
Qualifications
- Authorization to work in the U.S. permanently, without sponsorship.
- A high school diploma or GED equivalent; associate’s or bachelor’s degree in a related field preferred.
- At least 2 years of experience in administrative support, document management, records management, or a closely related clerical role.
- Proficiency with Microsoft Office Suite, including Word, Excel, Outlook, PowerPoint, and SharePoint.
- Experience with document scanning, PDF conversion (Adobe Acrobat or equivalent), and electronic file management.
- Ability to obtain and maintain an FDA background investigation and security access card (fingerprint return must be “favorable”).
- Ability to lift and move boxes weighing up to approximately 15 lbs. on a routine basis.
- Strong attention to detail and ability to maintain high accuracy (99%+) in data entry, document indexing, and records tracking.
- Ability to work independently and in a structured, compliance-driven environment with minimal supervision.
- Experience with federal laboratory or regulated environment recordkeeping is a plus.
- Familiarity with a Laboratory Information Management System (LIMS) or similar database is a plus.
Location
- Jefferson, Arkansas (Arkansas Human and Animal Food Laboratory – ARHAFL)
- Lakewood, Colorado (Denver Human and Animal Food Laboratory – DENHAFL)
- Lenexa, Kansas (Kansas City Human and Animal Food Laboratory – KCHAFL)
- Jamaica, New York (New York Human and Animal Food Laboratory – NYHAFL)
- Bothell, Washington (Seattle Human and Animal Food Laboratory – SEAHAFL)
- Irvine, California (Irvine Human and Animal Food Laboratory – IRVHAFL)
- Alameda, California (San Francisco Human and Animal Food Laboratory – SANHAFL)
- Atlanta, Georgia (Atlanta Human and Animal Food Laboratory – ATLHAFL)
Working Hours
This is a full-time, on-site position. Core hours are Monday through Friday, 8:00 AM – 4:30 PM local time. Contractor services are not required on Federal holidays or when the laboratory is officially closed. Limited episodic telework may be authorized for database entry tasks during inclement weather using government-furnished equipment.
Benefits
- Health, financial, and retirement benefits
- Paid leave
- Professional development
- Tuition assistance
- Work-life programs
- Award programs for exceptional performance and superior demonstration of service standards
Equal Opportunity Employer
We are an Equal Opportunity Employer (EOE). Qualified applicants are considered for employment without regard to age, race, color, religion, sex, national origin, sexual orientation, disability, or veteran status.
Application Instructions
Applicants must be authorized to work in the U.S.