Compliance, Training & Documentation Specialist supporting document management and compliance at Johnson & Johnson. Hybrid role based in Somerset, NJ with responsibilities across various operational aspects.
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 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
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
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