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Job 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.

Required 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.