Overview

Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing.  Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA.  Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Job Summary

The IFA Slides department is looking for a candidate to be apart of a fast-paced, supportive manufacturing team to assist with preparation of autoimmune diagnostic Immunofluorescence Assays (IFA) cell culture slide products. Opportunites for advancement and career growth while performing, mammalian cell culture, immunofluorescence cell suspension and slide preparation activities.  

Responsibilities

 Key Accountabilities

• Assists with the activities associated with the manufacture of IFA slide products in accordance with written instructions and schedules. 
• Assists with the maintenance, growth, harvesting and purification of HEp-2, rat intestinal, Crithidia, Neutrophil and other cell types according to established procedures.
• Inspects IFA cell culture slide products for acceptability according to written Manufacturing Documents.
• Assists with the evaluation of raw materials, in-process cell suspensions and fixed slides associated with IFA cell culture slide products.
• Maintains detailed Device History Records, laboratory notebooks and/or any associated documentation for all manufacturing and evaluation activities in accordance with current Quality Systems Regulations (QSRs).
• Prepares, calibrates, operates and cleans equipment used in the growth of cells and the manufacture of IFA cell culture slide products according to Standard Operating Procedures (SOPs).
• Maintains manufacturing equipment according to SOPs as requested by supervisor.
• Assists with experimental activities related to process validation and nonconformance investigations for IFA cell culture slide products as requested by supervisor.
• Informs supervisor of equipment needs and other supplies required to avoid interruptions in production schedules. Informs supervisor of broken or deteriorating equipment.
• Maintains work area and laboratory in a clean and orderly manner. Performs Friday Clean-up responsibilities in a thorough and timely manner.
• Follows established safety and environmental procedures. Reports all safety hazards immediately.
• Other duties may be assigned.

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

Qualifications

Minimum Knowledge and Experience:

• Bachelor's degree (B.A.) or (B.S.) in the biological, chemical or related sciences
• 0-1 years of applicable laboratory experience. 
• Basic knowledge of biological and chemical laboratory procedures.
• Ability to operate basic laboratory equipment.
• Knowledge of FDA and ISO regulations.
• Basic knowledge of computer operation with the ability to use MicrosoftÒ Word and Excel.
• Experience in one or more of the skills below is preferred:

  Mammalian Cell Culture

  Medical Device Manufacturing

  Automated or semi-automated manufacturing equipment 

   

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

Salary Range:

$23/hr - $29/hr

Individual compensation is based on the candidate's experience, skills, knowledge, education, certifications, internal equity, budget and or other business and organizational needs.