QC Technologist I

Introduction

Werfen

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:

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.

This is a 1st shift position. Hours: Monday-Friday, 5:00am-1:30pm.

This is a 6-month temporary assignment, with potential for extension or conversion depending on individual performance and business needs.

The base hourly range for this role is currently $24.00/hr. to $29.00/hr. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

Responsibilities

Key Accountabilities

Essential Functions:

• 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.

Internal Networking/Key Relationships:

• Quality Release, Quality Engineering, and Manufacturing Persononel

Qualifications

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

Technical Qualifications:

• 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.

Competencies:

• Attention to Detail: Basic ability to pay close attention to detail is required
• Accuracy: Work is accurate and completeness of records
• Outstanding Performance Standards: Demonstrated ability to meet department goals
• Communication: Good written and verbal communication skills
• Discretion: Acts Honest, Loyal, trustworthy
• Multi-Tasking: Basic ability to Juggle Priorities, and support changing business needs
• Collaboration: Basic ability to actively develop a network to bring best solutions to the team or customer
• Independence: self-motivated
• Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
• Takes Initiative: Serves as a role model for “Quality First”
• Problem Solving: Promptly and effectively handles basic issues and problems

Travel Requirements:  

• No

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 [email protected] 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.

www.werfen.com