QC Technologist III

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.

About the role

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, the role 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.

Responsibilities

• 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 turnaround 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.
• Coordinate and assist with investigations and resolution of complaints, non-conforming material, and product performance issues, including recommending and organizing test protocols for investigation.
• Perform testing of biological raw materials, including range generation or characterization, and organize and complete associated paperwork.
• Manage concentration selection and release as required.
• Organize and schedule basic testing requirements with minimal supervision.
• Perform testing and prepare reports as required, such as environmental monitoring reports or investigation of out-of-specification results.
• Track and analyze trends related to release testing and 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 deemed necessary by the technical review team.
• Serve as a subject matter expert in at least one product line.
• Submit complex change orders to update procedures as required.
• Interact independently with cross-functional teams to obtain information on testing, provide feedback, and demonstrate critical evaluation of testing requests.
• Assist the cross-functional team to investigate and resolve issues.
• 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.

Requirements

• High school diploma required; Bachelor’s degree in Science or equivalent experience preferred.
• Without related degree: A minimum of five (5) years of previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required.
• With related degree: A minimum of four (4) years of 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) environment 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

• 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 Resource Planning (ERP) systems.
• Must occasionally lift up to 25 lbs.
• Advanced attention to detail and accuracy.
• Demonstrated ability to meet department goals.
• Good written and verbal communication skills.
• Acts honestly, loyally, and trustworthily.
• Advanced ability to juggle priorities and support changing business needs.
• Advanced ability to actively develop a network to bring the best solutions to the team or customer.
• Self-motivated and works under minimal supervision.
• Demonstrates professionalism during all interactions within the company, with customers, and third parties.
• Serves as a role model for “Quality First” by continuously improving what matters most to customers.
• Promptly and effectively handles advanced issues and problems with minimal supervision or management.

Pay

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.