QC Technologist I / Phlebotomist
Werfen
Summary
The QC Lab Technologist I is responsible for the execution of a broad range of bench test procedures used in the QC testing of finished goods prior to release, assisting with investigations of product performance, routine validation studies, and housekeeping within the Quality Control (QC) laboratory. The QC Lab Technologist I maintains the documentation of approved QC Standard Operating Procedures (SOP) in compliance with applicable regulations and ISO standards.
Job description
Job Summary
The QC Lab Technologist I is responsible for the execution of a broad range of bench test procedures used in the QC testing of finished goods prior to release, assisting with investigations of product performance, routine validation studies, and housekeeping within the Quality Control (QC) laboratory. The QC Lab Technologist I maintains the documentation of approved QC Standard Operating Procedures (SOP) in compliance with applicable regulations and ISO standards.
Key Accountabilities
- Perform testing of finished goods per relevant SOP.
- Assist with testing as required for product validation and process validation on existing products.
- Maintain proper laboratory housekeeping and ensure adequacy of supply levels in the QC laboratory by informing appropriate personnel of low supply levels as required.
- Document all finished goods test results and maintain appropriate records in QC (including electronic records), as required.
- Maintain product testing database and trending associated with product specifications as specified in laboratory SOPs.
- As required, assist with testing for investigation and resolution of complaints, non-conforming material, and product performance issues.
- Perform testing and prepare basic out-of-specification reports, as required.
- Ensure and maintain compliance with the Company's quality system requirements through training and adherence to policies, procedures and processes.
- Other duties as assigned.
Minimum Knowledge & Experience Required for the Position
- High school diploma required; Bachelor's degree in Science or equivalent experience preferred.
- Understanding of Good Laboratory Practices (GLP) preferred.
- Previous experience in a Quality Control (QC) lab and/or Quality Assurance (QA) role within regulated medical device manufacturing or In-Vitro Diagnostic device (IVD) manufacturing preferred.
- Phlebotomy certification a plus.
- Knowledge of FDA-GMP/QSR and ISO standards for quality a plus.
Skills & Capabilities
- Good written and verbal communication skills.
- Ability to work as part of a team.
- Basic skills with common laboratory techniques, such as pipetting and use of balances.
- Basic skills with Microsoft Office suite.
- Basic skills with Large Enterprise Resources Planning (ERP) a plus.
- Must occasionally lift up to 25 lbs.
Requirements
- High school diploma required; Bachelor's degree in Science or equivalent experience preferred.
- Understanding of Good Laboratory Practices (GLP) preferred.
- Previous experience in a Quality Control (QC) lab and/or Quality Assurance (QA) role within regulated medical device manufacturing or In-Vitro Diagnostic device (IVD) manufacturing preferred.
- Phlebotomy certification a plus.
- Knowledge of FDA-GMP/QSR and ISO standards for quality a plus.
- Good written and verbal communication skills.
- Ability to work as part of a team.
- Basic skills with common laboratory techniques, such as pipetting and use of balances.
- Basic skills with Microsoft Office suite.
- Basic skills with Large Enterprise Resources Planning (ERP) a plus.
- Must occasionally lift up to 25 lbs.
Company overview
Werfen is a global leader in specialized diagnostics, founded in 1966 in Barcelona, Spain as a family-owned innovative company. The organization has established itself as a worldwide authority in five key clinical areas: Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant diagnostics. With headquarters in Barcelona and technology centers strategically located in the United States and Europe, Werfen operates directly in 30 countries and serves more than 100 territories through distributors. The company achieved remarkable financial performance with worldwide sales exceeding €2.2 billion in 2024, supported by a workforce of over 7,000 employees globally. Werfen's comprehensive portfolio includes advanced diagnostic systems, reagents, laboratory automation solutions, and point-of-care testing platforms that enable healthcare providers to deliver precise and timely patient care. Their innovative technologies span from blood gas analyzers with hemolysis detection capabilities to automated immunoassay systems and specialized diagnostic assays. As a vertically integrated diagnostics company, Werfen maintains complete control over research, development, manufacturing, and distribution, ensuring quality and reliability across their product lines while continuously advancing diagnostic science to address critical healthcare challenges worldwide.