Manufacturing Associate 1

Werfen•San Diego, CA

8h•Onsite

About The Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain, and a worldwide leader in specialized diagnostics in areas like Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. They also have an Original Equipment Manufacturing (OEM) business line for customized assays and biomaterials. Werfen operates directly in 30 countries and through distributors in over 100 territories, with Headquarters and Technology Centers in the US and Europe, and a workforce of more than 7,000. Their success stems from focus in rapidly evolving diagnostic areas, commitment to customers, and dedication to innovation and quality, aiming to provide healthcare professionals with valuable solutions to improve hospital efficiency and patient care. The Manufacturing Associate position at Werfen Autoimmunity is critical for manufacturing and/or testing various Autoimmune-related diagnostics products. This role involves manufacturing and/or testing components of diagnostic kits used globally for autoimmune disorder diagnosis. Manufacturing Associates work in a specialized team, utilizing advanced automated equipment and instrumentation for manufacturing and testing in-process components and raw materials. Employees contribute to product quality through troubleshooting and developing quality improvements within multiple value streams. Work is performed under department supervision and adheres to the company’s Quality Management System. This specific position is within the Biotechnologies Manufacturing team.

Requirements

Bachelor’s degree in biological or related sciences required.
Certificate program or A.S. degree with 3-4 years relevant experience in a life sciences laboratory may be substituted for a degree.
0-1 years of life sciences laboratory experience required.
Basic understanding of basic laboratory practices and procedures.
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.
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.
Curiosity and commitment to continuous learning.

Nice To Haves

Experience in a regulated manufacturing environment in the healthcare sector strongly preferred.

Responsibilities

Under supervision follows standard operating procedures, work instructions, and other procedures for routine manufacturing and/or testing.
Participates in the bulking and/or evaluation of in-process components and reagents according to procedures.
Packages, fills, and operates equipment to ensure in-process components are completed (if applicable).
Maintains detailed Device History Records and/or any other associated documentation for all manufacturing activities.
Operates and cleans equipment and instrumentation for routine manufacturing and/or testing.
Assists with evaluations of raw materials (if applicable).
Follows established safety and environmental procedures.
Maintains lab and work area in a clean and orderly manner.
Complies with applicable Werfen standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety (EHS), Human Resources and other regulatory and company policies.
Reflects Werfen Values in the quality of work and in working relationships.