Johnson & Johnson Careers
Quality Specialist II
Requisition ID: 2661180923
Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting a Quality Specialist II to be located in Lititz, 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 Specialist II will be responsible for maintaining quality assurance programs, procedures and controls, as well as supporting manufacturing processes from end to end.
In this role, you will be responsible for ensuring both products and quality system elements are in compliance with good manufacturing practices and good laboratory practices as established in the code of local government regulations and company procedures.
Responsibilities include but are not limited to:
- Document investigations and rationales which are technically accurate and regulatory compliance focused for all quality documentation including non-conformances, corrective actions, and audit observation responses, quality reports, metrics.
- Conduct, execute and document thorough low risk/low complexity investigations and CAPAs.
- Ensure timeliness of deliverables through proactive intervention.
- Troubleshoot low risk/low complexity quality/compliance issues, using experience, ingenuity, and creativity to provide solutions to a moderate range of root causes.
- Implement quality and compliance improvement programs and initiatives and participate in continuous improvement projects.
- Review compliance records, specifications, procedures and other documents, as required by procedure. Limited approval responsibilities.
- Responsible for executing revisions to established procedures with limited impact to other functions or regions.
- Assists in document preparation/presentation for regulatory agency visits and Corporate/internal audits.
- Support batch record review as needed by performing quality review of production records including manufacturing, packaging, and laboratory documents
- A minimum of a Bachelor's degree is required. A degree in the Sciences or Engineering is preferred.
- A minimum of 2 years’ experience in a cGMP regulated environment is required.
- A minimum of 1 year in a customer support environment is required.
- Laboratory experience is required.
- Knowledge of cGMP requirements and current FDA enforcement issues is a must.
- Strong interpersonal skills with high energy 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.
- This position may require up to 5% 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..
J & J Consumer Inc. (6101)