QC Technologist III

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 III is responsible for the execution of a broad range of bench test procedures used in raw material qualification, the testing of finished goods prior to release, the investigations of product performance, and for conducting routine validation studies, as well as assisting with routine maintenance of the Quality Control (QC) laboratory.  The QC Lab Technologist III works with cross-functional teams to resolve product performance issues and maintenance of QC Standard Operating Procedures (SOP) in compliance with applicable regulations and ISO standards. Additionally, QC Lab Technologist III supports investigations and performs in depth analysis of the trending of finished product testing data.  The QC Lab Technologist III manages basic projects independently of management.

 

The base hourly range for this role is currently $34.00/hr. to $39.00/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.
• Perform testing for product validation and process validation on new and existing products and demonstrate the ability to understand the validation.  Assist with the development of validation, including feedback on testing requirements and turn around time.
• Maintain proper laboratory housekeeping and supply levels in the QC laboratory, including submission of purchase requisitions and inventory adjustments and exhibiting knowledge of product usage based on planned production to ensure safety stock and continued supply.
• Document all test results and maintain product release records (including electronic records).
• Maintain product testing database and trending associated with product specifications as specified in laboratory SOPs.
• As required, coordinate and assist with investigations and resolution of complaints, non-conforming material and product performance issues, including recommending and orga- nizing test protocols for investigation.
• Perform testing of biological raw materials, including range generation or characterization. Organize and complete associated paperwork. As required, manage concentration selec- tion and release. Organize and schedule basic testing requirements with minimal supervi- sion.
• Perform testing and prepare reports as required, such as environmental monitoring reports or investigation of out-of-specification results, as required.
• Responsible for tracking and analyzing trends related to release testing. Ability to use analysis of trends to provide input on product issues and results.
• Perform testing and assist with preparation of reports for various special projects as dee- med necessary by technical review team.
• Responsible as a subject matter expertise in at least one product line.
• Submit complex change orders to update procedures as required.
• As required, interact independently with cross-functional teams to obtain information on testing, provide feedback and information, and demonstrate critical evaluation of testing requests.  Assist the cross-functional team to investigate and resolve issues.
• Exhibit ability to manage multiple projects/responsibilities with little supervision.
• 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, Research and Development, 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 pre- ferred.
• Work Experience:
  • Without Related degree: A minimum of five (5) years previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required
  • With Related degree: A minimum of four (4) years previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required
  • Previous experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD) strongly preferred.
• Thorough understanding of Good Laboratory Practices (GLP) required.
• Practical experience with laboratory controls, internal audits, and lab training/maintenance.
• Phlebotomy certification a plus.
• Knowledge of FDA-GMP/QSR and ISO standards for quality.

Skills & Capabilities:

Technical Skills:

• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team.
• Proficiency with common laboratory techniques, such as pipetting and use of balances.
• Proficiency with Microsoft Office suite.
• Proficiency with Large Enterprise Resources Planning (ERP).
• Must occasionally lift up to 25 lbs.

Competencies:

• Attention to Detail: Advanced 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: Advanced  ability  to  Juggle  Priorities,  and  support  changing  busi- ness needs. Exhibit ability to manage multiple projects/responsibilities with little supervi- sion.
• Collaboration: Advanced ability to actively develop a network to bring best solutions to the team or customer
• Independence: self-motivated-works under minimal supervision
• Professionalism: Must demonstrate professionalism during all interactions within com- pany, customer and third parties
• Takes Initiative: Serves as a role model for “Quality First” by continuously improving on what matters most to customers
• Problem Solving: Promptly and effectively handles advanced issues and problems with minimal supervision or management.

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