Johnson & Johnson Careers
Senior Analyst, Quality Assurance - PART TIME
Requisition ID: 2941180604
Johnson & Johnson is recruiting for a Senior Analyst, Quality Assurance to be located in Raritan, New Jersey. This is a part time position, flexible schedule, 19.5 hours per week.
With $74.3 billion in 2014 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.
- Be responsible for supporting the oversight of the quality management system for Johnson & Johnson Sterility Assurance Services, Raritan.
- Be responsible for quality review of documentation including: service requests, reports and associated documentation, quality events and associated documentation, change controls, validation documentation, and other local quality records and procedural documents.
- Generate, tracking and trending quality metrics as needed. Identify trends and needs to elevate actions as required.
- Support the JJSA Service Manager, Raritan as a quality support during all quality audits
- Support requests for quality records, data or test reports by external authorities and Johnson and Johnson operating companies.
- Support process optimization associated with technical service requests at the JJSA Raritan Site
- Support on time closure of JJSA quality management system (QMS) records (i.e. change control, non-conformance, CAPA, audit observations)
- Prepare metrics and reports required for quarterly Quality Management System Review
- Administrate JJSA supplier qualification and maintain JJSA Approved Supplier List
- Support Records Management by:
- Liaising with Corporate RIM Operations on existing RIM program.
- Maintaining quality agreements with J&J franchises in support of sample processing at the Raritan Sterility Assurance Site.
- Archiving inactive documents on-site within the secured Records Management Library.
- Preparing documents for archiving an offsite location designed for protective storage.
- Provide guidance to the service and support teams, as well as organize training and lessons learned on quality management system related topics.
- Comply with site EH&S initiatives, audits or remediation activities as required
- Maintain quality and compliance in all aspects of work in accordance with cGMP.
- A BS in Engineering or Technical field preferred.
- A minimum of 4 years of experience in quality, compliance, manufacturing, engineering, or related field in an FDA regulated environment is required.
- Demonstrated capability to support and lead quality system activities is required.
- The ability to work with minimal supervision is required.
- Knowledgeable on good documentation and data integrity practices is required.
- Desire and ability to cross-train on skills and responsibilities associated with supplier quality, quality systems, and record management is required.
- This position will be based in Raritan, NJ and may require up to 10% domestic and/or international travel. This is a part time position, flexible schedule, 19.5 hours per week
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Raritan
Johnson & Johnson Services Inc. (6090)