Job DetailsJob Location: Irvine, CA 92618Position Type: Full TimeEducation Level: High SchoolSalary Range: $21.50 - $21.50 HourlyJob Title: Associate Technician, Packaging and Labeling   Role Level: Individual Contributor   Supervisor/Manager Title: Supervisor, Packaging and Labeling   Job Location & Environment: Irvine, CA- Corporate Office/ Controlled Cleanroom Environment and Pack Out Areas.   Job Description Summary: Manufacturing- Hourly/ Assembly Responsible for manufacturing activities related to the packaging and labeling of delivery systems and valves within the cleanroom and pack-out environment.   Job Responsibilities: Participate in packaging, labeling, and preparation of delivery system components within the cleanroom and pack out areas of JenaValve Production. Complete training as outlined in Training Plans. Be aware of Health and Safety information for the applicable processes utilized in the organization. Complete all packaging and labeling operations in accordance with work instructions, good manufacturing practices, and good documentation practices in compliance with the JenaValve quality system. Print, inspect, and apply labels in accordance with approved labeling specifications, ensuring accuracy of lot numbers, expiration dates, and product identifiers. Perform visual inspection of packaged products and labels to ensure compliance with specifications. Identify basic labeling or packaging issues and escalate concerns to supervisors or quality personnel as appropriate. Develop familiarity with packaging, labeling, and documentation processes through training and hands-on experience. Advocate for the company's core values. Review packaging and labeling documentation for accuracy, completeness, and GMP compliance. Support inventory handling, counting, and control of raw materials, labels, and work-in-process components used in packaging and labeling operations. To adhere to all aspects of JenaValve’s QMS in the completion of their duties. Maintain reliable and consistent attendance to support production operations, including punctual arrival and the ability to work full scheduled shifts and overtime as required. Any other reasonable duties as requested by management. QualificationsRequired Education and Experience: High school diploma or equivalent required. Candidates without a diploma may demonstrate equivalent competency through a validated external assessment designed to evaluate comprehension, language, and related abilities at a high school level. Manufacturing experience preferred Experience in packaging, labeling, or manufacturing operations in a regulated or cleanroom environment preferred. Familiarity with procedures, equipment and tools used in the medical device industry or other regulated industries preferred.   Skills and Abilities Required for This Job: Must be able to work effectively and collaborate within cross-functional teams. Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel. Ability to take initiative and perform hands-on packaging and labeling tasks. Ability to focus on single tasks that require high attention to detail. Able to prioritize multiple tasks with high visibility. Must be able to perform routine work with minimal supervision. Must be able to perform non-routine work with close supervision. Must be able to complete the applicable training requirements. Ability to understand GMP procedures. Ability to read, comprehend and speak English, and good communication skills required. Basic computer skills.   Physical Requirements: Ability to work in a controlled cleanroom environment while wearing full cleanroom gowning including gown/coveralls, gloves, mask, hairnet, boot covers, and other PPE as needed. Ability to stand or sit for prolonged periods while performing detailed assembly tasks. Ability to perform fine motor skills and repetitive hand motions required for manual assembly and inspection. Ability to lift, carry, push, or pull materials and equipment weighing up to approximately 50 pounds. Ability to visually inspect small components with or without corrective lenses. Ability to work in a temperature-controlled environment with limited mobility while gowned. Must be able to push, pull, twist, climb, balance, stoop, kneel, and crawl. Must be able to perform repetitive motions such as reaching and grasping.