Specialist- Compliance, Training, Documentation

About the position 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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine. We are searching for the best talent for the Specialist, Compliance, Training, & Documentation. This hybrid position will be located in Somerset, NJ. Alternate locations may be considered in Titusville, NJ; Shepherdsville, KY; and Toronto, Ontario, Canada. Customer Service and Channel Operations (CSCO) is the centralized customer service function for the Deliver NA organization handling sales order management functions on behalf of Johnson & Johnson Pharma Operating Companies in the U.S. As part of NA Janssen DELIVER team, the Compliance, Training & Documentation Specialist is responsible for delivering and supporting Document Management, Quality and Compliance for Customer Service teams. This includes providing outstanding advisory and analytical support to internal and external customers enabling the compliant execution of critical customer focused operations. This role is responsible for data collection, validation, and reporting and knowing where to acquire the data to provide relevant insights with recommendations which enables management to make strategic decisions. Additionally, this role provides Quality & Compliance expertise on applicable projects.

Responsibilities

• Support and continually work within parameters established by a risk-based Quality Management System framework.
• Ensure readiness to deliver exemplary customer service in an efficient, quality driven manner while adhering to standard business procedures.
• Complete Departmental/Regional Change Control documentation and deliverables to ensure the on-time completion.
• Support internal and external audits to verify that regulatory and quality requirements have been met.
• Complete weekly, monthly and quarterly SOX controls within close week.
• Provide Quality & Compliance expertise on applicable projects.
• Lead and/or support key departmental/cross-functional projects, as assigned, by developing and applying in-depth knowledge of business processes and systems, as well as project management skills.
• Facilitate remediation of any audit findings.
• Use continuous improvement tools and methodology, including Process Excellence, LEAN, and project management, to identify, evaluate, challenge, develop solutions, and optimize business processes that drive measurable improvement.
• Regularly communicate in all directions to keep associates, peers, and Management informed of project status, process changes, and opportunities.
• Conducts After Action Review (AAR) post-implementation and finds opportunities to continuously improve.
• Benchmark internally and externally, regionally and globally, to capture, share, and implement standard methodologies accordingly.
• Assist Senior Leaders with development and implementation of organizational and strategic plans designed to improve efficiency of department processes, using technology and other platforms to standardize, leverage and/or eliminate manual interactions wherever possible.
• Support change management strategies by applying change management principles and tools.
• Serve as the Subject Matter Expert (SME) regarding documentation management, Quality and Compliance, and Job Function Curriculums (JFC).
• Optimize and standardize SOX reports under assigned Customer Service and Channel Operations function.
• Develop, implement, and evaluate metrics with relevant insights for customer service in the areas of Document Management, Quality and Compliance to drive efficiency, productivity, and operational improvements.
• Own data reporting in the areas of Document Management, Quality, and Compliance.
• Support the on-time completion of Annual Training Record Review (ATRR) and lead on-time completion of controlled document periodic review.
• Review and maintain SOPs/WIs in Tru-Vault to ensure all are consistent across CSCO functions and updated before deadline.

Requirements

• Minimum of a Bachelor’s/University or equivalent degree is required.
• A minimum of 0-2 years experience; 3-5 years of related experience preferred
• Experience in Quality, Compliance, Document Management/Control, Technical Writing, or Supply Chain position
• Understanding of Sarbanes-Oxley Act (SOX)
• Experience within a regulated, fast-paced business environment
• Ability to excel in ambiguous environment
• Leadership experience in project management
• Proficiency in MS Office applications (Word, PowerPoint, Excel, Access, Outlook)
• Demonstrated time management skills with consistent track record to handle multiple contending priorities/deadlines, ability to act with a sense of urgency, and deliver expected/exceeding results
• Strong Collaboration, business partnering, influencing, and negotiating skills to develop and maintain effective business partnerships
• Proven process, problem-solving, analytical, organizational, and detail-oriented skills

Nice-to-haves

• Master's degree preferred.
• Experience in audit participation
• Pharmaceutical experience
• Experience with the administration of electronic document management systems
• Knowledge of Quality System processes and applicable regulations
• Experience in SAP (ATLAS/4HANA)
• Solid understanding of Process Excellence/LEAN methodology and/or certification
• Business knowledge of other Deliver Janssen Supply Chain functional areas and end-to-end process understanding

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

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