Staff Quality Engineer - (Job Number: 0805962)

Staff Quality Engineer - (Job Number: 0805962) DescriptionJohnson & Johnson Consumer Products, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Quality Engineer, located in Skillman, New Jersey. Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. develops and markets baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands JOHNSON'S Baby and BAND-AID Brand, as well as leading skin care brands such as AVEENO and CLEAN & CLEAR. The Staff Quality Engineer is responsible for the overall QA management of a group of contract manufacturers engaged in the production of OTC drugs, Medical Devices and Cosmetic products. Selection and qualification of new contract manufacturing locations. Support established contract manufacturing sites by conducting cGMP audits, driving compliance and quality improvement initiatives, assisting in the resolution of process/product nonconformance events, monitoring/resolving product complaints, creation of Annual Drug Product Reviews, reporting contract manufacturer performance metrics and conducting management reviews. Represent QA on new project and improvement teams by guiding sourcing decisions, qualifying new suppliers, setting quality/compliance requirements, developing SOP's & specifications, and providing technical transfer/validation support. Must have a Bachelors of Science in a technical discipline and a minimum of 6 years experience in an OTC drug, cosmetic or pharmaceutical FDA regulated environment. Must also posses a broad knowledge of Quality Assurance principles/practices in the pharmaceutical, biological, OTC drug, and/or cosmetic product industry. Knowledge of cGMP requirements and current FDA enforcement issues is required. An ASQ certification would be a preferred. A working knowledge of process validation, cleaning validation, and microbiological equipment train design standards is required. Must have the ability to lead compliance audits. Must have experience with MS Office Tools. Excellent analytical, prioritization, communication, and strong leadership skills. Ability to work independently with minimal supervision. Management experience would be a plus. New product launch experience is preferred. This position is located in Skillman, NJ. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Apply Now