Quality Assurance Manager
Our client in Conshohocken is hiring a Quality Assurance Manager to join their team!
Job Type : Full-Time / Permanent
Hours : Monday Friday, 8 : 00 AM 5 : 00 PM - Onsite 5 days / week
Reports To : Director of Quality Assurance
Summary
The Quality Assurance Manager holds a pivotal role within our organization, tasked with the critical responsibility of ensuring that all products and services meet the established quality standards.
Responsibilities :
- Up-to-date understanding of FDA regulations, cGMP "Current Good Manufacturing Practice" and internal policies / procedures.
- Manage deviations, nonconformances, complaints, safety incidents, Corrective and Preventive Actions (CAPAs), and Supplier Corrective Action Requests (SCARs) ensuring prompt investigation and implementation of effective corrective measures.
- Conduct thorough root cause analyses and assessments of CAPAs to determine the adequacy of investigations.
- Establish, assess, and refine quality metrics, offering insights and recommendations to drive continuous improvement.
- Oversee the review of HCT / P donor records to ensure final product release aligns with standard operating procedures and regulatory / accrediting agency requirements.
- Supervise the review of quality control records, encompassing equipment cleaning, maintenance, environmental monitoring, and supply inspections.
- Contribute to training efforts on quality-related processes and corrective actions.
- Support the implementation of new projects and product development initiatives.
- Assist in the formulation of validation / qualification protocols and summary reports, adhering to regulatory requirements and industry best practices.
- Evaluate and authorize validation / verification protocols, execution data, and summary reports.
- Facilitate internal, client, and regulatory agency audits to guarantee compliance with regulatory and certification standards, as well as internal policies and procedures.
- Cultivate professional relationships with customers, partners, and vendors.
- Oversee direct reports and monitor individual performance.
- Maintain meticulous records in accordance with standard operating procedures.
- Participate in offsite business meetings and conferences to stay abreast of industry developments and trends.
Education & Experience :
- Bachelor’s degree required in biological science or related field.
- At least 5 years of experience in quality in an FDA regulated environment for HCT / Ps and / or medical devices (or related field), with progressive management responsibility.
- Valid Driver's license.
If you or someone else you know are interested in this role, please send updated resumes to [email protected] for immediate consideration
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