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 **Job Function:** Quality **Job Sub** **Function:** Quality Systems **Job Category:** Professional **All Job Posting Locations:** Cornelia, Georgia, United States of America **Job Description:** **About MedTech** Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for **Change Control Analyst 1** to be in **Cornelia, GA** **SECTION 1: JOB SUMMARY** Responsible for ensuring documents submitted with changes conform to established standards. Also responsible for providing support to contributors to the change control process.Support record management processes and other quality systems and processes for the applicable site(s). Serve as a local PLM owner for implementing the process for change management support for controlled documents within the PLM system. This includes the creation of a new document, revisions to existing documents and verifying that all existing procedures affected by the change have been followed per governing change control procedures. **SECTION 2: DUTIES & RESPONSIBILITIES** Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: + Assists in reviewing 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. + Assists change originators in change control processes and system tools. + Generates routine reports and metrics on the change process as needed. + Assists on document and data control business practices and helps reduce change cycle time. + Assists in conducting internal audits of the change management process. + Supports process improvement and assists in implementation. + Analyzes routine processes and systems for alignment to business strategy. + Checks change implementation and identifies items for closure of completed change orders. + Review Change Orders for compliance, quality, integrity, clerical correctness and procedure conformance. + Resolve deficiencies, inconsistencies and discrepancies in the documentation identified for change with the change owner. + Modify file attachments, create change tasks, and change/add approvers if needed. + Collaborates and communicates with other functions and PLM users as necessary for managing change control and to resolve issues related to the change order and provide guidance on the PLM process. + Verify and ensure that the proposed change is compiled, prepared, reviewed, approved per established procedures and aligned with relevant regulations. + Confirm all files are accessible and able to be opened and read + Manage and prioritize site specific change orders + Add PLM users for applicable sites + Support the creation and maintenance of change control procedures as necessary. + Provides PLM user support and training as needed. + Supports internal and external audits + Maintains and generates metrics and reports regarding the PLM process. + Support cross-functional global project teams to address business issues, including but not limited to asset relocation, label changes, etc. + Escalate PLM system issues as necessary for resolution + Support the organization in the evaluation / investigation of product complaints, nonconformances, and audit observations, and implementation of action plans to eliminate root cause of nonconformances. + Coordinates the systematic review, approval, and destruction of offsite records. + Conducts assessments of departmental compliance and offsite vendor compliance with records management policies and procedures. + Support the maintenance of records retention schedule (RRS). + Coordinates with departments for vital records protection requirements. Supports implementation of consistent solutions for vital record protection. + Supports coordination of acquisition or divestitures related to records. + Provides guidance regarding scanning and true copy process to employees. + Facilitate record requests and compliance documentation related to the Legal Hold System and litigation documentation support requests. + Provides periodic complaint (DHR) reports and assists facilitator and Quality Engineers as assigned. + Manage Quality Systems records in accordance with offsite storage requirements. + Review, revise, and disposition document changes within areas of expertise per applicable procedures for record management. + Work effectively with the other quality and operations associates to ensure consistent and compliant systems. + Support and lead quality system improvements, which result from internal audits, or other system indicators. + Support ongoing continuing efforts to improve Quality Systems (In-Process reporting, software upgrades to systems, etc.) + Work in team environment behaving in a CREDO based respectful manner. + Comply with all job specific safety procedures and utilize PPE when necessary. + Comply with quality system requirements as defined within procedures and instructions. + Utilize applicable software systems as needed for the job (e.g. ComplianceWire, PLM, etc.) + Support LEAN and Six Sigma Initiatives. + Accurately complete records as defined within the job procedures (e.g. manual and/or electronic documentation). + Consistently meet required Training due date targets. + Follow current compliance regulations and standards. + Support Plant Diversity Process. + Ensure safe working conditions and practices in the department. + Responsible for communicating business related issues or opportunities to next management level + For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable + Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures + Performs other duties assigned as needed **SECTION 3: EXPERIENCE AND EDUCATION*** + University/bachelor’s degree or Equivalent + Generally, Requires 0-2 Years Work Experience **SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS** _*_ + Intermediate or advanced computer and database management skills. + Competency in the ETHICON network office application software. + Team skills including excellent verbal and written communication and interpersonal relation skills including conflict management. + Must have demonstrated analytical problem-solving skills. + Prefer knowledge of lean concepts such as Kaizens, Value Stream Mapping, Poke Yoke, etc. + Knowledge of Operating Procedures and related computer systems required. + Strong proofreading, written and verbal communication skills. + Able to interface and collaborate with all levels of management and work with minimal supervision. + Analytical ability for metrics + Problem solving for issue resolution + Ability to lift up to 40 pounds required _Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act._ _Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (_ _ra-employeehealthsup@its.jnj.com_ _) or contact AskGS to be directed to your accommodation resource_ **The anticipated base pay range for this position is :** Additional Description for Pay Transparency: