Coordinator I, Quality Records at Werfen GmbH

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

04 May, 26

Salary

0.0

Posted On

03 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

DHR Review, Product Release, Quality Control, cGMP Compliance, Record Auditing, Traceability, ERP System, Discrepancy Resolution, Regulatory Audits, Quality System Adherence, Data Metrics, Time Management, Attention To Detail, Self-Motivation, Teamwork, Communication

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 Job Summary The Quality Records Coordinator is responsible for the review and audit of Manufacturing and Quality Control (QC) related records associated with the release of products in manufacturing, primarily product Device History Records (DHRs). The Quality Records Coordinator oversees the review of DHRs in order to complete the final release of accepted sub-components and finished good products. Responsibilities Key Accountabilities: Review DHRs for assigned products; as appropriate, approve product release through the Enterprise Resource Planning system (ERP). Audit DHRs to ensure accuracy, legibility, and traceability Continually work to achieve assigned review time goals; meet unscheduled in workload as necessary to ensure timely release of product. Responsible to scan/archive completed DHRs Facilitate resolutions for discrepancies in DHR quality records; work with document preparers to resolve ques- tions, inconsistencies, or missing data issues. Remain current with all specifications and requirements on which quality records are based. Remain up to date with current Good Manufacturing Processes (cGMP), as well as with manufacturing’s mate- rial/product process flow. Provide data and metrics related to accuracy, completeness and cycle times for records being reviewed. Ensure priority to urgent matters. Provide additional administrative support as directed. Participate in regulatory audits as needed. Ensure and maintain compliance with the company’s quality system requirements through training and adher- ence to policies, procedures, and processes. Other duties as assigned. Carries out duties in compliance with established business policies. Interface with all functions and levels of management as needed. Other duties as assigned, according to the changing needs of the business Quality Coordinator Activities: DHR Review and Release Deviation process (Affected DHRs) Nonconformance process Validation DHR Review Networking/Key relationships: Quality Control Planning Engineering Manufacturing Qualifications Minimum Knowledge & Experience Required for the Position: High school diploma; Bachelor’s degree (Life Sciences) a plus. Minimum one year’s previous related Quality Records/Quality Assurance experience preferred; previous experi- ence within a regulated medical device manufacturing or pharmaceutical environment strongly preferred. Skills & Capabilities: Knowledge of cGMP, GDP, FDA, and ISO preferred. Working knowledge of Microsoft Office. Experience with large enterprise resource planning (ERP) system and accounting software packages preferred. Previous regulatory audit experience a plus. Technical writing background/experience a plus Must be self-motivated and could work with minimal supervision; must also be able to work as part of a team. Good communication, organizational, and time management skills; ability to pay close attention to detail. Ability to work as part of a team. Ability to identify and correct problems. Travel Requirement: None 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 Quality Records Coordinator is primarily responsible for reviewing and auditing Manufacturing and Quality Control records, especially Device History Records (DHRs), to complete the final release of sub-components and finished goods products. This involves ensuring accuracy, legibility, and traceability of records while meeting established review time goals.