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

Participates in the preparation of autoimmune diagnostic products, utilizing the Bioflash technology platform, following established procedures. Major duties include Bioflash bead and reagent preparation activities and the preparation of controls and conjugates for the Bioflash product lines.

Key Accountabilities

• Prepares Bioflash product bulks and solutions required for antigen coupling according to written manufacturing documents and schedules.
• Researches and corrects problems with Bioflash production according to established Standard Operating Procedures (SOPs) and procedures.
• Assists with the evaluation of raw materials, in-process materials and finished reagents associated with Bioflash products according to written procedures.
• Prepares and performs validations for all Bioflash equipment according to written protocols.
• Maintains detailed Device History Records, laboratory notebooks and/or any associated documentation for all manufacturing, evaluation and development activities in accordance with Quality Systems Regulations (QSRs). Assists with the generation and implementation of Engineering Change Orders (ECOs) for manufacturing documents and SOPs.
• Prepares, calibrates, operates and cleans equipment used in the manufacture of Bioflash products according to written SOPs.
• Investigates, analyzes and carries out corrective actions for Bioflash product performance or manufacturing problems in conjunction with supervisor and the assistance of others.
• Informs supervisor of laboratory equipment needs and other supplies required to avoid interruptions in production schedules. Informs supervisor of broken or deteriorating equipment.
• Carries out all tasks required to improve product performance/quality and/or process efficiency for Bioflash autoimmune diagnostic products as requested by supervisor.
• Maintains work area and laboratory in a clean and orderly 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.

Minimum Knowledge and Experience:

Bachelor's degree B.A. or B.S. or equivalent in the biological or related sciences

• 1-2 years of laboratory experience.
• Working knowledge and/or laboratory skills in the area of solution preparation, immunochemistry conjugation techniques, computer operation procedures and laboratory equipment operation.
• Knowledge of QSR and Engineering Change Orders (ECOs) systems as they apply to diagnostics manufacturing.

Salary Range:

$23/hr - $32/hr

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