Coordinator I, Quality Records
Share
Job Location:
San Diego, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Department:
Job Summary
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 7000 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. Were 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 manufacturings 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 companys 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; Bachelors degree (Life Sciences) a plus.
- Minimum one years 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 individuals 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 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 7000 employees around the world comprise our Werfen team.
Required Experience:
IC
Key Skills
- Microsoft Access
- Quality Assurance
- Data Collection
- HEDIS
- ISO 9001
- Root cause Analysis
- Medical office experience
- Quality Systems
- Nursing
- Quality Control
- Quality Management
- Manufacturing
About Company
Since 1959, we’ve harnessed our passion to create a history of innovative specialized diagnostics breakthroughs in vitro diagnostics, improve the quality of test results, and enhance patient care.
