Quality Control Technologist -Transfusion

Overview

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. 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.

Job Summary

Perform incoming, in-process, and final release testing, along with document review in the Quality Control commercial GMP laboratory.

Responsibilities

• Performs incoming raw material, in-process, final testing and inspection of products according to approved Standard Operating Procedures (SOP’s) within defined timeframes.
  • Test methods/equipment used include: PCR, gel electrophoresis, and DNA extraction.
    • Analyze data using product software.
      • Master the use of BASIS and NGS applications for data analysis.
• Maintains accurate, legible, and complete records according to Current Good Manufacturing Procedures (cGMP’s) and ALCOA data integrity requirements.
• Maintains work area, equipment, department, and all storage areas in a clean, neat, and orderly manner.
• Reports out-of-specification results and deviations to the department supervisor and/or manager.
• Affords assistance with investigations, root cause analyses, and reports for out-of-specification results and deviations.
• Maintains supply inventory and identifies any products required.
• Affords assistance to the department supervisor and manager in maintaining and compiling Device History Records.
• Performs equipment calibration, cleaning, and maintenance.
• Overtime may be required which may include holidays and weekends.

Qualifications

• Education: Bachelor’s degree in a science related field required. (EX. Biology, chemisty, Biomedical).
• Experience: Minimum 1 year laboratoy experience required (This can include Univeristy lab experience).
• PREFERRED: One or more years of experience in a GMP commerical laboratory (pharmacuetical or medical device industry).
• Desired: Experience using manual and automated pipettes to dispense volumes of 0.1 ul through 10 mL.
• Experience performing polymerase chain reaction (PCR).

Skills & Capabilities

• Pipetting solutions of varying volumes.
• Performing DNA extraction.
• Running a thermocyclcer.
• Performing gel electrophoresis.

Reasonable Accommodations

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

Networking/Key Relationships

This role will work with quality control, quality assurance, and operations personnel on a daily basis. This role will work with MTS (manufacturing technical support), technical support, and research & development personnel on an occasional basis.

Closing

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.