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Quality Systems Specialist II – Systems, Process & Analytics
Requisition ID: 3647180216
Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting a Quality Systems Specialist II – Systems, Process & Analytics to be located in Lancaster, 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.
Quality Systems Specialist II – Systems, Process & Analytics is responsible for monitoring Quality Systems processes and metrics to drive completion of tasks, maintain compliance, identify quality system performance/process gaps and facilitate continuous improvement processes.
This position will also perform operational activities related to the Electronic Document Management System (EDM), Learning Management System (LMS) and Electronic Records Management System (ERMS). S/He may act as SME for one or more business processes/systems, will provide support to internal stakeholders and establish strong relationships to drive process improvement and ensure efficient processes.
Responsibilities include but are not limited to:
- Act as owner for Quality Systems file libraries, SharePoint, shared mailboxes and network drives for organization and access.
- Monitor the impact and effectiveness of programs & processes through data, the development of surveys and other feedback mechanisms. Interpret data/feedback, discuss with stakeholders, suggest improvements and drive solutions to further enhance process effectiveness and sustainability.
- Create process flow diagrams and contribute to the development/simplification of processes and procedural documents. Create/revise SOPs, work instructions and training materials; provide training to system users/team members.
- Develop business and project plans, communications and content to support business process and training activities.
- Achieve and maintain SME status and participate in Community of Practice (COP) for one or more business processes/systems, including: Document Management, Retention and Training.
- Lead or support all quality system upgrade/validation/migration activities. Monitor functionality and communication between systems and related applications.
- Develop, collect and tabulate metrics related to Quality Systems and processes (Training, Document Management).
- Perform qualitative and/or quantitative analysis to identify trends and where trends are identified, make recommendations for and coordinate implementation of solutions for improvement.
- Monitor quality systems data to drive completion of tasks, maintain compliance, identify quality system performance/process gaps, drive continuous improvement processes.
- Apply knowledge of internal systems or tools to provide relevant insights to metrics. Present Quality Systems topics and data at COP, Team Meetings, Quality Council, and other forums as requested by leadership.
- Support/perform operational activities, including: document review and processing in Electronic Document Management System (EDM) and Learning Management System (LMS) and Electronic Records Management System (ERMS) transactions.
- Provide support as a subject matter expert (SME) for Training, Document Control and/or Retention systems during audits and inspections.
- A minimum of a Bachelor’s degree is required.
- A minimum of 2 years of related experience is required.
- A minimum of 1 year work experience in pharmaceutical and/or biological manufacturing operation in Quality Assurance and/or Quality Systems is preferred.
- Knowledge of the applicable regulations including GxPs and working knowledge of other major regulatory agencies regulations and guidance’s is highly preferred.
- Proficiency with MS Office, including Word, Excel and Power Point, Adobe, SharePoint and ability to quickly learn new systems is required.
- Previous experience with the use of document management and training systems, electronic methods to gather data/feedback and create metrics, and Process Mapping/Improvement is preferred.
- Advanced experience in Excel data, tables and charts is preferred.
- Advanced SharePoint development experience is preferred.
- This position may require up to 10% travel to local sites as needed.
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)