Overview
Salary Range
$21.50 - $21.50 Hourly
Position Type
Full Time
Education Level
High School
Description
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.
Qualifications
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.
