Coordinator I, Quality Records

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 goods products. This is a temporary, non‑exempt position compensating $26.00/hr – $31.00/hr. Key Accountabilities Review DHRs for assigned products and, as appropriate, approve product release through the Enterprise Resource Planning system (ERP). Audit DHRs to ensure accuracy, legibility, and traceability. Work to meet assigned review time goals; take on unscheduled workload as necessary to ensure timely release of product. Scan/archive completed DHRs. 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. Maintain up‑to‑date knowledge of current Good Manufacturing Practices (cGMP) and with manufacturing’s material/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 adherence to policies, procedures, and processes. Carry out duties in compliance with established business policies. Interface with all functions and levels of management as needed. Perform 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 prior related Quality Records/Quality Assurance experience preferred; previous experience 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) systems and accounting software packages preferred. Previous regulatory audit experience a plus. Technical writing background/experience a plus. Must be self‑motivated and able to work with minimal supervision; also a team player. Good communication, organizational, and time‑management skills; attention to detail. Ability to work as part of a team. Ability to identify and correct problems. Travel Requirement None Equal Employment Opportunity Statement 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 View email address on click.appcast.io for assistance. #J-18808-Ljbffr Werfen