Associate FDA Specialist at Certified Laboratories Inc – Melville, New York

The Associate FDA Specialist supports the FDA Detention team by performing entry-level administrative and operational tasks. This role focuses on learning core FDA processes, ensuring accurate documentation, and assisting in the preparation of detention packages. The Associate FDA Specialist develops foundational knowledge of FDA import requirements and laboratory workflows while contributing to efficient and compliant operations. This individual will uphold our purpose – so the world can trust in what it consumes by fostering a culture aligned to our mission and values:

Purpose: So the world can trust in what it consumes.

Mission: Partner with customers to deliver innovative scientific solutions and expertise.

Values: start with the customer, commit to safety and quality, drive to deliver, act with integrity and support the team.

Responsibilities:

Assists with data entry, document preparation, and tracking of FDA detention files. Support sampling coordination, logging information into LIMS, and ensuring accuracy of records. Learn FDA terminology, documentation standards, and departmental procedures. Collaborate with team members to ensure timely completion of tasks. Escalate issues to senior team members or supervisors as appropriate.

• Assist with data entry, document preparation, and tracking of FDA detention files.
• Support sampling coordination, logging information into LIMS, and ensuring accuracy of records.
• Learn FDA terminology, documentation standards, and departmental procedures.
• Collaborate with team members to ensure timely completion of tasks. Escalate issues to senior team members or supervisors as appropriate.
• Maintain lab safety practices and follow company compliance protocols.
• Check email and Microsoft Teams daily for updates, assignments, and communications.
• Foster strong working relationships by learning team roles and responsibilities in the lab.
• Organize and maintain scanned documents, ensuring proper naming conventions and folder navigation (Teams, Scans, FDA Packets for Review, QCV Docs, etc.).
• Perform daily scanning of QCV documents, filing appropriately.
• Print missing Standards or QCVs from instruments and ensure proper documentation.
• Name samples accurately during scanning, including circling where required.
• Check in and out of ADP timekeeping system.
• Complete HSI training as assigned.
• Update pH 4, 7, and 10 files with new Certificates of Analysis (COA).
• Locate and review new COAs, CVs, and FDA packages.
• Read and verify data on master sheets; identify and correct errors.
• Prepare Quality Control (QC) and FDA reports including VIDAS Salmonella and Listeria (Presumptive, Confirmation, and QC reports).
• Update overdue Turnaround Time (TAT) Excel sheets.
• Monitor Labware for sample accuracy, including removing and relinking reports when needed.
• Maintain organized documentation and physical papers for traceability and audit readiness.

Qualifications:

• High school diploma required; associate or bachelor’s degree preferred.
• 0–1 year of experience in laboratory, regulatory, or administrative support roles.
• Strong attention to detail and organizational skills.
• Basic computer proficiency and ability to learn LIMS systems.
• Strong organizational, time management, attention to detail and problem-solving skills.
• Communication skills (verbal, written, interpersonal).
• Written and verbal communication skills, with the ability to interpret complex business, technical and regulatory documents.

Physical Demands/Work Environment:

• Sitting for extended periods of time
• Dexterity of hands and fingers to operate a computer keyboard, mouse and to handle other
• communications/computer components
• Occasionally lift and/or move up to 25 pounds.
• Extensive car and air travel
• Potential exposure to odors, fumes, airborne particles, hazardous chemicals, and microbiological pathogens