What are the responsibilities and job description for the Design Assurance Technician position at IMMY?
Description
Job purpose
Entry-level, hands-on support of DA activities under supervision across all product lifecycle stages. Execution of studies, collecting data, and maintaining documentation per SOP and QMS requirements.
Key duties and responsibilities
· Execute routine testing, including analytical performance, stability, and flex studies, under DA Scientist or Senior DA Scientist supervision.
· Prepare reagents, aliquots, specimens, and other study materials.
· Support usability studies (formative and summative) by preparing reagents and materials, assisting participants, and ensuring protocol adherence.
· Maintain accurate lab records, including line data forms, worksheets, and notebooks, ensuring traceability.
· Perform basic data entry, preliminary calculations, and execute study tasks under supervision.
· Support risk management activities by documenting hazards, controls, and observations during studies.
· Maintain lab organization and equipment readiness.
· Assist with design change assessments and training activities as directed.
Qualifications
Required
· Associate’s or Bachelor’s in a scientific field.
· Strong attention to detail and documentation rigor.
· Ability to follow approved protocols and SOPs for study execution.
Preferred
· Basic lab skills: pipetting, dilutions, specimen prep.
· Familiarity with GLP/GMP, QMS, ISO 13485, and FDA design control requirements is a plus.
Equal Opportunity Employment: IMMY is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind 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, and local laws. IMMY will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including, but not limited to, recruiting, hiring, promotion, termination, leaves of absence, compensation, and training.
Background Check Policy: All offers of employment at IMMY are contingent upon clear, acceptable results of a thorough background check. IMMY performs all background checks in compliance with EEOC and FCRA regulations and all other applicable federal, state, and local laws.