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.

Position 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 finished goods, primarily product Device History Records (DHRs). The Quality Records Coordinator oversees the archives of DHRs, Device Master Records (DMRs) and other quality records, and is responsible for maintaining accuracy, legibility, traceability, and retrieval of such records. Additionally, the Quality Records Coordinator is responsible for ensuring quality records associated with the release of product for packaging and/or distribution are complete and accurate.

Key Accountabilities

Essential Functions:

• Review DHRs for assigned products; as appropriate, approve product release through the Enterprise Resource Planning system (ERP).
• Continually work to achieve assigned review time goals; meet unscheduled in workload as necessary to ensure timely release of product.
• Facilitate resolutions for discrepancies in DHR quality records; work with document preparers to resolve questions, 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 manufacturings material/product process flow.
• Provide data and metrics related to accuracy, completeness and cycle times for records being reviewed. ? Identify areas in need of improvement, particularly with regards to accuracy, completeness, and cycle times of the quality record process.
• Ensure priority to urgent matters. Identify issues and work to implement corrective action. Provide additional administrative support as directed.
• As needed, participate in regulatory audits.
• Work on assigned special projects as directed.
• Provide additional administrative support as directed.
• Ensure and maintain compliance with the companys quality system requirements through training and adherence to policies, procedures and processes.
• Other duties as assigned.

Budget Managed (if applicable): N/A

Internal Networking/Key relationships:

• To be determined based on department needs

Skills & Capabilities:

Minimum Knowledge & Experience Required for the Position:

• High school diploma or equivalent experience preferred; Bachelors degree (Life Sciences) a plus.
• Three (3) to five (5) years previous related Quality Records/Quality Assurance experience; previous experience within a regulated medical device manufacturing or pharmaceutical environment preferred.
• 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 have the ability to 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.

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