Job Summary

Werfen Autoimmunity Manufacturing Associates play a critical role in the manufacturing and/or testing of a variety of Autoimmune-related diagnostics products. This position is responsible for the manufacture and/or testing of components of diagnostic kits used by clinicians around the world for the diagnosis of autoimmune disorders. Our Manufacturing Associates work in a highly specialized team environment, using advanced automated equipment and instrumentation to manufacture and test in-process components and raw materials. Employees help ensure product quality by participating in troubleshooting and developing quality improvements within our multiple value streams. Work is performed under department supervision and in accordance with the company’s Quality Management System.

Employees working in the ELISA team manufacture ELISA plates, calibrators and controls, and all other related components.

Employees working in the IFA team manufacture IFA slides, controls, bulks and all other related components.

Employees working in the QUANTA Flash and Aptiva team manufacture coupled beads, calibrators, controls, and all other related components.

Employees working in the Product Testing team test products from all product lines (ELISA, IFA, QUANTA Flash, and Aptiva) and all other related components.

Employees working in the Biotechnologies Manufacturing team manufacture raw materials for use in the manufacturing processes for all product lines (ELISA, IFA, QUANTA Flash, and Aptiva).

Key Accountabilities

• Under supervision follows standard operating procedures, work instructions, and other pro-cedures for routine manufacturing and/or testing.
• Participates in the bulking and/or evaluation of in-process components and reagents ac-cording 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 test-ing.
• 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.
  
  

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Minimum Knowledge and Experience:

Education: Bachelor’s degree in biologicial or related sciences required. Certificate program or A.S. degree with 3-4 years relevant experience in a life sciences laboratory may be substitued for a degree.

Experience: 0-1 years of life sciences laboratory experience required. Experience in a regulated manufacturing environment in the healthcare sector strongly preferred.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities

• 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.

Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate. This position is very active and requires varying levels of mobility.