Laboratory Records & Administrative Specialist

Laboratory Records & Administrative Specialist

Looking for an innovative organization and the opportunity to learn and grow professionally? We can help! We are seeking a Laboratory Records & Administrative Specialist to support 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. This position plays a key role in ensuring the integrity and accessibility of analytical laboratory records by managing document scanning, electronic submission, records archiving, and administrative support under FDA's Laboratory Information Management System (LIMS).

The Laboratory Records & Administrative Specialist will provide on-site administrative support services including scanning and electronic submission of analytical worksheets, laboratory records management and archiving, records destruction, and general administrative support — all in support of the FDA's initiative to modernize laboratory document management through its Laboratory Information Management System (LIMS).

You will:

• 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).
• Log 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.
• 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.
• Assist with 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.

You might be the professional we're looking for if you have:

• 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.

Positions are available at the following FDA Human and Animal Food Laboratory locations. Please indicate your location preference when applying:

• 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)

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.

We offer outstanding benefits, including health, financial, and retirement benefits, as well as paid leave, professional development, tuition assistance, and work-life programs. Our award programs acknowledge employees for exceptional performance and superior demonstration of our service standards. Full-time and part-time employees working at least 20 hours a week on a regular basis are eligible to participate in our benefit programs. Other offerings may be provided for employees not within this category.

Terrestris is 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.

Applicants must be authorized to work in the U.S.

DILBERT © 2018 Scott Adams. Used By permission of ANDREWS MCMEEL SYNDICATION. All rights reserved.