Quality Systems Specialist

Johnson & Johnson is currently seeking a Quality Systems Specialist to join our Quality Control department located in Ringaskiddy, Co. Cork.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Are you ready to make a significant impact in the field of document control and quality systems? Do you have a keen eye for detail and a passion for compliance? If so, we want to hear from you!

What you will be doing:

This position is responsible for carrying out tasks and projects related to document control for Janssen Sciences Ireland (JSI) UC as the need arises by Good Manufacturing Practice (GMP). These activities include administration owner of the Electronic Document Management System (EDMS), preparation/submission of GMP documentation into and retrieval from archive, and the management of controlled documents through the review, approval, circulation and revision processes.

What impact you will also have:

• Provides support and direction to all departments (QA, QC, Operations, Maintenance, etc.) With respect to Quality Systems to ensure business, quality and compliance goals are met. Partners with other departments to ensure that Documentation programs and Records Management policies are completed in a compliant and efficient manner.
• Supports the development and management of GMP compliance systems through the following activities: – Completion of tasks related to management Document Control and Records management in respect GMP regulatory requirements:
• Provide mentorship on the site document control and records management procedures and policies.
• Reviews received documents for conformance to site systems specifically EDMS and GDP requirements.
• Liaises with document owners in respect of approval schedules and implementation of new or revised documents.
• Provides feedback from document review to the document owners.
• Administrative tasks within the EDMS system including but not limited to: – Granting User access to the system and assigns privileges.
• Coordinates routing of SOPs and other GMP regulated documents.
• Supervises documents during the review and approval processes and advises relevant personnel accordingly.
• Participates in upgrade and improvement activities of the system as appropriate.
• Generates reports and metrics from the system.
• Develops and applies systems and procedures related to the EDMS system.
• Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.
• Coordinates the Records Management Policy for the site and carries out tasks related to the storage and archiving of GMP documents related to JSI/JPS, in line with J&J records retention standards and guidelines. – Prepares and catalogues documents for archival.
• Coordinates with internal and external groups for the archival of documents.
• Leads document retrieval from archive storage as requested.
• Supervises access to on-site document storage.
• Audits internal and external document storage/archive systems.
• Provides training in Good Documentation Practice (GDP) and GMP to personnel.
• Develops and maintains training materials for provision of GDP and GMP training to site personnel.
• Supports Inspection readiness as documentation and Records Management SME.
• Deputies for the Quality Systems Team Lead as appropriate.

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