SR COMPLIANCE SPECIALIST- QUALITY AUDITOR-5601140318
Description
Advanced Sterilization Products, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Compliance Specialist, located in Irvine, CA.
Advanced Sterilization Products (ASP) a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP has offices around the world. For more information, please visit www.aspjj.com.
The Senior Compliance Specialist is responsible for scheduling and executing internal audits of ASP Supply Chain processes, and supporting external inspection preparations and execution. The Senior Compliance Specialist will report directly to Compliance Manger, Quality Operations.
The Senior Compliance Specialist will execute internal audits in accordance with defined procedures and annual audit schedule. The Senior Compliance will ensure proper reporting, response review and approvals, communication of issues, and use of tracking and trending tools. The Senior Compliance Specialist will review and approve investigations and corrective action plans arising from internal/external audit observations to assure that they meet the required site and MD&D standards of investigations, corrective action plans and effectiveness checks. The Senior Compliance Specialist will be responsible for weekly and monthly reporting of Supply Chain Compliance metrics and tracking and trending of the data. The Senior Specialist will support creation, deployment, and maintenance of internal audit schedule. The Senior Compliance Specialist will participate in quality and compliance projects such as inspection readiness. The Senior Compliance Specialist will support external inspections of health authorities and notified bodies.
Qualifications
A minimum of Bachelor's degree is required. A degree in science, business, engineering, or related field is preferred. Candidate should have a minimum of 5 to 8 years of experience in medical devices or pharmaceutical industry. Candidate should have a minimum of 3 to 5 years in quality compliance roles. Candidate should have a working knowledge of 21CFR Part 820, 210, 211, ISO 13485. Candidate should have experience in conducting compliance audits and generating audit reports. Candidate should have experience in supporting regulatory inspections. Candidate should have excellent communication and presentation skills. Candidate should be capable of building internal and external partnerships. Candidate should be detail oriented and capable of multi-tasking. Candidate should have the ability to interpret and apply regulations and industry best practices. Strong investigation skills such as root cause analysis. Candidate should have computer literate in Microsoft Office – Outlook, Word, Excel, PowerPoint, Access and it is strongly preferred they have experience with an ERP Systems, EDMS, LIMS, EQMS.
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J2W:LI NA
Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)
Job Function: Quality Assurance
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