Johnson & Johnson Careers
Quality Associate III – Change Control
Requisition ID: 2441180920
Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting a Quality Associate III – Change Control 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 Quality Associate III – Change Control will be responsible for supporting the preparation, review, processing, approval and closure of change controls. This individual will assist the change control owners in the research and writing of change control documents, coordinating their review, approval and execution.
In this role, you will be responsible for identifying relevant SMEs that can gather/provide relevant information, (e.g. specification, master documents, validation/qualification materials, and other required data) in order to effectively explain the proposed change, document the rationale for the change and identify deliverables required to implement the change in accordance with procedures.
Responsibilities include but are not limited to:
- Coordinate the Change Control Committee Meetings.
- Act as Site Local EtQ Administrator ensuring compliance by performing training and administration of the EtQ modules.
- Support and guide change control owners during change control initiation and throughout the process for procedural requirement adherence.
- Review change controls for completeness, procedural alignment and adherence to change control commitments.
- Facilitate Fort Washing Plant Change Control training sessions and meetings as applicable and assist in the periodic review of quality systems.
- Assist in the preparation of Quality Council data and submit monthly and quarterly reports on metrics established.
- Act as liaison for the Change Control APR data contributions.
- Participate as a team member on both internal and external project teams in response to changes, interfacing primarily with technical, quality assurance and manufacturing/operations groups.
- Drive the timely implementation and closure of change controls while ensuring compliance to applicable quality standards and change control procedures.
- Act as liaison with Home Office and participates in Change Control Community of Practice
- Other duties as assigned.
- A minimum of a Bachelor's degree (or equivalent experience) is required. A focus degree in the Sciences or Engineering technologies is preferred.
- A minimum of 5 years’ experience in a cGMP regulated environment is required.
- Prior change control management experience (i.e. administration, execution) is required; technical writing background is highly preferred.
- Experience in a quality and technology environment with one of the following areas: GMP manufacturing, technology, validation, analytical sciences, microbiology and engineering is required.
- The ability to read, analyze and interpret common scientific and technical documents is required.
- Organizational skills and the ability to adapt to changing requirements is preferred.
- The ability to effectively present information and communicate clearly in written and oral form to all levels of management is required.
- Demonstrated knowledge of computer and quality management systems and Microsoft Office skills required.
- Experience in GMP technical oriented training related to change control process is preferred.
- This position may require up to 10% domestic 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)