Johnson & Johnson MedTech · 13 hours ago
Finished Goods Release QA Coordinator
San Lorenzo, CA
Full-time
Onsite
Mid Level
4+ years expJohnson & Johnson MedTech is committed to healthcare innovation and improving patient outcomes. The Finished Goods Release QA Coordinator will coordinate the final product release process, ensuring compliance with regulatory requirements and maintaining high-quality standards.
Hospital & Health Care
Responsibilities
Prepares documentation that shows the results of tests performed and prepare custom reports on results
Review and complete transactions such as, but not limited to, batch records, Sterilization Certificates of Processing and appropriate records retention in Manufacturing and Quality Systems to release Finished Goods products
Advise about any non-conformance related to the QA inspection and test methodologies. Generate the Non-Conformance Report (NC) to the impacted Department
Evaluate the precision and accuracy of products, production equipment, and/or testing equipment
Use LIMS and JDE software to document the inspection results and disposition to product prior to release
Collect or oversee the collection of Finished Goods and Retain samples at the sterilization site when needed for testing and for evaluation
Performs data analysis and recommends disposition of material. Segregate Finished Goods samples and Retain Samples according to the requirements
Generate Certificate of Analysis (COA) as per Client’s and other Plants Requests
Support Sterilization Diversion activities
Work with two different Sterilization Suppliers and assists as required
Qualification
Required
An Associate Degree (in a science or technical field is preferred) with a minimum of four (4) years of experience within Quality Assurance Department is required; or Bachelor's degree in science with four (4) years professional experience is required
10% travel requirement between Ethicon Locations, Domestic and/or international travel is required
Availability to work overtime, various work schedules, which may include 1st, 2nd, 3rd shifts and/or 12-hour daily shifts, including weekends and holidays is required
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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