We are seeking a motivated and detail-oriented
Lateral Flow Assay (LFA) Technician to support the production of rapid diagnostic tests. The technician will be responsible for preparing reagents, assembling test components, operating specialized dispensing and lamination equipment, and performing quality control testing. This role requires precision, excellent documentation practices, and the ability to work in an ISO 13485 manufacturing environment.
Key Responsibilities
- Perform manufacturing steps for lateral flow assays, including:
- Reagent preparation, conjugation, and buffer formulation.
- Striping/dispensing reagents onto membranes and pads (using Biodot equipment).
- Lamination and cutting of cards into strips (using Kinematic equipment).
- Assembly and packaging of test devices.
- Conduct in-process quality checks (e.g., visual inspection, functional strip testing, dimensional checks).
- Assist with routine quality control testing of incoming raw materials and finished devices.
- Maintain accurate batch records, equipment logs, and documentation in compliance with ISO 13485 and FDA 21 CFR Part 820.
- Operate and maintain laboratory and manufacturing equipment, including calibration and cleaning.
- Follow Good Manufacturing Practices (GMP) and maintain a clean and safe work environment.
- Report deviations, nonconformances, or equipment issues to the supervisor promptly.
- Support validation activities (IQ/OQ/PQ) and continuous process improvements as required.
Qualifications
- Required:
- Associate’s degree in Biology, Biochemistry, Chemistry, Biotechnology, or related field, OR equivalent hands-on laboratory/manufacturing experience.
- 1+ year experience in a diagnostics laboratory or medical device manufacturing environment.
- Strong pipetting and reagent handling skills.
- Ability to work accurately with small volumes and delicate materials (e.g., nitrocellulose membranes).
- Excellent attention to detail and adherence to SOPs.
- Good communication and teamwork skills.
- Preferred:
- Experience with lateral flow assays, immunoassays, or diagnostic test manufacturing.
- Familiarity with striping/dispensing and lamination equipment (e.g., Biodot, Kinematic).
- Knowledge of ISO 13485, GMP, and FDA QSR requirements.
- Experience in a cleanroom or controlled environment.
Location
- Onsite at DCN Dx facility in Carlsbad, CA
- Monday - Friday, Day Shift
Benefits
- Medical, Dental, Vision
- Life/AD&D, Short-Term Disability, Long-Term Disability
- Paid Time Off, Holiday Pay
- 401k, 3% Contribution
- Amazing Colleagues and Culture
AAP/EEO Statement
DCN Diagnostics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
