Quality Control Technologist -Transfusion

Werfenlife SA.; New Jersey; On-site; USD 60,000 - 90,000; Full time

Job summary

Werfen is seeking a Quality Control Technologist - Transfusion in the United States. The role involves performing incoming, in-process, and final release testing in a GMP QC lab, reviewing documents, and ensuring compliance with cGMP and ISO regulations.

The ideal candidate has a Bachelor’s degree in a science field and at least 1 year of lab experience, with preference for GMP/commercial lab exposure. The position may require extra hours, and flexibility is expected.

Qualifications

• Education: Bachelor’s degree in a science related field required (e.g., Biology, chemistry, Biomedical).
• Experience: Minimum 1 year laboratory experience; GMP experience in pharma or medical devices preferred.
• Desirable: PCR experience and automated/manual pipetting across a range of volumes.

Responsibilities

• Performs incoming, in-process, and final testing and inspection per SOPs within defined timeframes.
• Uses test methods/equipment including PCR, gel electrophoresis, and DNA extraction.
• Analyzes data with product software; maintains accurate, cGMP compliant records.
• Follows ISO 13485, 21 CFR Part 820 and other medical device regulations; maintains clean work area.
• Reports out-of-spec results and deviations; assists investigations and root cause analyses.

Skills

Pipetting

Data analysis

Thermocycler operation

Education

Bachelor’s degree in a science related field

Tools

PCR

Gel electrophoresis

DNA extraction

Job description

Quality Control Technologist -Transfusion

Country

United States

Shift

1st

About the Position

Introduction

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.

Overview

Job Summary

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

Responsibilities

Key Accountabilities

• 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.
• Performs all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards).
• 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.
• Assists with investigations, root cause analyses, and reports for out-of-specification results and deviations.
• Monitors supply inventory and identifies any products required.
• Assists department supervisor and manager in maintaining and compiling Device History Records.
• Perform equipment calibration, cleaning, and maintenance.
• Overtime may be required which may include holidays and weekends
• Ability to follow regulations, including: ISO 13485, 21 CFR Part 820, and other medical device regulations.

Performs other duties and responsibilities as assigned.

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), technicalsupport, and research & development personnel on an occasional basis.

Qualifications

Minimum Knowledge & Experience required for the position:

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)

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

Skills & Capabilities:

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

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 [e-mail] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.