Document Control Administrator

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.

About the role

The Document Control Administrator is responsible for making administrative decisions to meet departmental and internal customer needs. Responsible for ensuring documents submitted with changes conform to established standards. Also responsible for providing support to contributors to the change control process.

This position is located in San Angelo, TX and may require up to 5% travel, both domestic and international.

Responsibilities

• Performs as business system administrator for at least one of the electronic quality systems in the plant, e.g. ADAPTIV, LIMS, Compliance Wire, EtQ. Provides back up and support as business system administrator for at least two other electronic quality systems.
• Reviews quality aspects of change documents submitted for accuracy and consistency with other documents.
• Proofreads and edits documents for style, grammar, spelling, format, and impact it may have on other documentation.
• Provides assistance to change originators in change control processes and system tools.
• Generates reports and metrics on the change process as needed.
• Consults on document and data control business practices and helps reduce change cycle time.
• Conducts internal audits of the change management process.
• Supports process improvement and implementation.
• Analyzes processes and systems for alignment to business strategy.
• Verifies change implementation and approves closure of completed change orders.
• Performs as Site Record Coordinator; serves as liaison between department coordinators and Records Manager; performs internal records management compliance assessments as needed and implements/coordinates inactive storage solutions provided by external storage vendor.
• Demonstrates a thorough knowledge of facility and organizational policies and procedures.
• Provides presentations and education to all levels of the organization on regulatory, corporate, and local policies and procedures.
• Responsible for leading and participating in cross-facility or plant teams as directed by Quality Systems Lead.
• Provides investigation, documentation, corrective action recommendations, and project management on assigned quality system improvements.
• Maintains necessary supplies and equipment.
• Provides periodic reports, completes special projects, and assists Quality Systems Lead as assigned – may act on behalf of the Quality Systems Lead to represent the site where Records Manager role is concerned.
• Performs a variety of other duties of a complexity commensurate with the job level as assigned or required.
• Complies with all applicable quality management system, environmental, safety, and occupational health policies (for example, ISO 13485, ISO14001 & OSHAS18001).
• Responsible for communicating business-related issues or opportunities to the next management level.
• Responsible for following all Company guidelines related to Health, Safety, and Environmental practices as applicable.

Requirements

• Education: Associate or equivalent level degree required.
• 6-8 years of related experience.
• Demonstrated competency in the ETHICON network office application software or ability to quickly achieve competency.
• Software expertise in multiple software applications as well as PC hardware knowledge.
• Team skills including problem solving, conflict management, communications skills – both verbal and written, analytical and systems thinking, and strong organizational skills.
• Department assessments for records management.
• Contract renewal and negotiation.
• Purchase Order submission for annual off-site records storage.

Skills

• Required Skills: Administrative Support, Communication, Compliance Management, Controls Compliance, Execution Focus, ISO 9001, Persistence and Tenacity, Problem Solving, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Report Writing, Standard Operating Procedure (SOP), Teamwork, Technologically Savvy.
• Preferred Skills: Windchill, EtQ, and Quin experience.