Johnson & Johnson Careers
QA Associate II - Complaints/Retain Room
Requisition ID: 8123180727
Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Associate II - Complaints/Retain Room to be located in Fort Washington, PA.
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.
The QA Associate II - Complaints/Retain Room will perform activities as per applicable Retain Room procedure for the identification and destruction of expired retain samples.
- Process product quality complaint investigations using the Product Quality Management System (PQMS).
- Interface and support J&J GMS (Global Medical Safety) with respect to reports of Adverse Events which may be related to product quality.
- Qualified Complaint Approver (if designated) and will be responsible to perform a documented review of complaint investigations to ensure the complaint record is accurate, complete, and in compliance with procedural requirements.
- Perform field sample visual inspection and document results as per procedure.
- Proactively identifies, evaluates, and prioritizes opportunities for continuous improvement for the complaint processes. Facilitates team identification of these opportunities.
- Receives and collects retain samples (Chemical Raw Materials, Packaging components, finished product) provided departments: Sampling and Inspection, packaging, and other departments as applicable. Logs samples in the retain samples log books and or appropriate electronic systems.
- Performs Annual Visual Inspection as per triggers identified by AVI procedure and issue results in the form of memos or reports to appropriate departments (example APR group).
- Adheres to procedural requirements for the receipt, storage and destruction of listed and recalled products.
- Perform other activities to ensure adherence of the Retain Room with McNeil policies and procedures and regulatory and as deemed necessary by QA management.
- Provide support during regulatory inspections/audits as directed. Support may be in the form of scribes, runner and document gathering.
- A minimum of a B.S. or B.A. College Degree is required. Science or Technical Degree is preferred.
- A minimum of 2 years of experience in a highly regulated environment is required
- Experience in pharmaceutical, consumer, OTC, or medical device quality or compliance setting is preferred.
- Demonstrated knowledge and expertise in quality processes and regulatory environment preferred.
- Experience with handling of product quality complaints is preferred.
- Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)
- Advanced computer skills, specifically in Microsoft Word, Excel, and Power Point.
- This position may require up to %5 travel as business demands.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
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-Pennsylvania-Fort Washington
J & J Consumer Inc. (6101)