Technologist II, QC Lab at Werfen GmbH

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

30 Apr, 26

Salary

0.0

Posted On

30 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Bench Test Procedures, Raw Material Qualification, Finished Goods Testing, Product Performance Investigation, Validation Studies, Laboratory Maintenance, SOP Documentation, GLP, Statistical Analyses, Change Orders, Quality System Compliance, Written Communication, Verbal Communication, Pipetting, Microsoft Office Suite, Attention To Detail

Industry

Medical Equipment Manufacturing

Description

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 Position Summary: The QC Technologist II 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 Technologist II assists with resolving product performance issues and maintains the documentation files of approved QC Standard Operating Procedures (SOP) in compliance with applicable regulations and ISO Standards. Responsibilities Key Accountabilities Essential Functions: Perform testing of biological raw materials and finished goods per relevant SOP. Perform testing for product validation and process validation on existing products. Perform testing and prepare reports as required for environmental monitoring or investigation of out-of-specification results, as required. Perform testing and assist with preparation of reports for various special projects as deemed necessary by technical review team. Responsible for tracking relevant trends. Maintain proper laboratory housekeeping and supply levels in the QC laboratory, including submission of purchase requisitions and inventory adjustments. Document all test results and maintain product release records (including electronic records). Document existing product/process validation test results (including electronic records). Maintain product testing database and perform relevant statistical analyses associated with product specifications as specified in laboratory SOPs. As required, assist with investigation and resolution of complaints, non-conforming material and product performance issues. Submit basic change orders to update procedures 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, 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 preferred. Thorough understanding of Good Laboratory Practices (GLP) required. Work Experince: Without Related degree: A minimum of two (2) years previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required With related degree, a minimum of one (1) years previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required Experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device ( IVDD) strongly preferred. Phlebotomy certification ba plus. Skills & Capabilities Required Skills: Strong 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) preferred. Must occasionally lift up to 25 lbs. Competencies: Attention to Detail: 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: Intermediate ability to Juggle Priorities, and support changing busi- ness needs. Exhibit ability to manage a minimum of one project/responsibility with little supervision. Collaboration: 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 intermediate issues and problems. These may require some research but still has a higher level employee driving the inves- tigation and resolution. 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 NAtalentacquisition@werfen.com 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

Responsibilities

The QC Technologist II executes a wide range of bench tests for raw material qualification and finished goods release, while also conducting routine validation studies and assisting with laboratory maintenance. This role involves maintaining documentation for SOPs and contributing to the resolution of product performance issues in compliance with regulations.