Quality Control Technologist -Transfusion

Werfen; Warren Township (NJ); On-site; USD 55,000 - 75,000; Full time

Job summary

Werfen is seeking a QA/QC Laboratory Associate to perform incoming, in-process, and final release testing in a GMP setting, review documentation, and help ensure product quality.

You will use PCR, gel electrophoresis, DNA extraction, and pipetting, maintain accurate records per cGMP/ALCOA, and work with quality and operations teams in Warren, NJ. Bachelor's in science and 1 year lab experience required; some GMP lab experience preferred.

Qualifications

• Bachelor's degree in a science-related field.
• Minimum 1 year laboratory experience; GMP experience preferred.
• Experience with PCR, DNA extraction, gel electrophoresis, and pipetting; knowledge of cGMP and ALCOA data integrity.

Responsibilities

• Performs incoming raw material, in-process, final testing and inspection of products according to approved SOPs within defined timeframes.
• Test methods/equipment 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 cGMP and ALCOA data integrity requirements.
• Performs all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations.
• 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.

Skills

Pipetting

DNA extraction

Thermocycler

Gel electrophoresis

Education

Bachelor's degree in science-related field

Tools

PCR equipment

Job description

About the Position

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), technical support, 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, chemistry, Biomedical).

Experience: Minimum 1 year laboratory experience required (This can include University lab experience). Preferred one or more years of experience in a GMP commercial laboratory (pharmaceutical 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 thermocycler.
• Performing gel electrophoresis.

Travel requirements: No travel requirements.

Equal Opportunity Employer

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.