Filler 1

About the role

As a Production Filler with Werfen's Autoimmunity business line, you will play a key role in manufacturing diagnostic products that help clinicians worldwide identify and diagnose autoimmune disorders. In this hands-on role, you will perform product bulking, filling, labeling, and packaging activities using specialized equipment and established processes while working in a collaborative team environment. By following Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), and the company’s Quality Management System, you will help ensure the highest standards of product quality, accuracy, and reliability, directly contributing to better patient care around the globe. This is an exciting opportunity for someone who has strong attention to detail, enjoys collaborative work, and wants to help contribute to Werfen's mission to improve patient outcomes. This role is full time on-site in San Diego, CA.

Responsibilities

• Assists with the activities associated with product filling and labeling in accordance with established procedures.
• Records work on Device History Records and/or any associated documentation in a timely manner for all manufacturing activities in accordance with the company’s Quality Management System.
• Prepares, calibrates, operates and cleans the equipment used in the bulking, filling and labeling of products according to Standard Operating Procedures (SOPs).
• Recognizes and reports any equipment malfunctions; makes necessary adjustments to equipment as trained and authorized.
• Maintains work area in a clean and orderly manner.
• Assists with the bulk manufacturing process as necessary including filtering, inspecting in-process bulks, performing double checks and additional support (if applicable).
• Assists with evaluations of raw materials (if applicable).
• Assists in the Packaging Department as requested by management.
• Follows established safety and environmental procedures.
• Reports all safety hazards immediately.
• Complies with applicable Werfen policies, ISO, FDA and other Quality System regulations.
• Reflects Werfen Values in the quality of work and in working relationships.
• Other duties may be assigned.
• Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications

Education: High school diploma or a general education degree (GED). Experience: 0-1 years of work experience. Ability to operate filling and labeling equipment. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills

• Basic understanding of Good Manufacturing Practices.
• Strong attention to detail and commitment to quality.
• Attentiveness to details to spot flaws in products or problems with equipment to prevent quality issues.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, manufacturing documents and SOPs.
• Ability to apply common sense understanding to carry out detailed written or oral instructions.
• Ability to complete routine documentation of manufacturing activities.
• Ability to speak effectively before co-workers.
• Basic computer skills.
• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals.
• Ability to use the metric system.
• Ability to count items accurately.
• Problem-solving ability to troubleshoot and resolve issues.
• Time management skills to meet production goals without compromising quality.
• Ability to work collaboratively in a team environment.