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Quality Systems Specialist III

Company: J&J Family of Companies
Location: Lancaster
Posted on: April 30, 2021

Job Description:

Johnson & Johnson is currently recruiting for a Quality Systems Specialist III located in Lancaster, PA.Johnson & Johnson Consumer Inc., based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S Baby, BAND-AID, NEUTROGENA, TYLENOL, MOTRIN, and LISTERINE. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.Summary Under the direction of functional area management, the Quality Systems Specialist III will consult with internal partners to understand business goals and performance needs, develop and execute learning aligned to the business strategy. S/He will routinely engage with and influence with key stakeholders to ensure learning solutions support and positively drive desired outcomes. Primary responsibilities include the design and development of learning items (procedural documents, eLearning, on-the-job, instructor-led) to develop personnel and/or increase organizational effectiveness S/He may act as Subject Matter Expert (SME) on the Training process. Success in this role depends on the candidates ability to work cross-functionally to discover and articulate the business process and performance needs and translate them through the design and delivery of learning solutions.Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies policies, procedures and guidelines, this position: Ensure quality and compliance in all my actions by: All employees Attend GMP training on the schedule designated for my role and as appropriate for my role. Adhere to strict compliance with procedures applicable to my role. Exercise the highest level of integrity in the tasks that I perform. In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace. Embrace a behavior of employee involvement and commitment to doing the job right the first time.People Managers Ensure employees under your scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year. Promote an environment of employee involvement in the workplace. Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees. Learning & Development Review/approve training documentation to ensure best practices of adult learning are applied while meeting customer needs Demonstrate an advanced understanding of learning processes and methodology in order to provide appropriate learning solutions; identify alternate, non-training solutions when appropriate Consult with stakeholders to evaluate performance gaps, streamline existing business and operational flows, define process models, and create/revise associated training documentation and assessments Rapidly assimilate new information, quickly grasp complex technical concepts and make them easily understandable in text and pictures to design/develop: process flow diagrams, procedural document content, instructor-led, on the job (OJT) and eLearning Remain current on learning and development/industry-related tools, techniques, strategies and practices in order to provide relevant, informed consultative advice to clients; share learning best practices with teams and stakeholders Deliver training and/or support local Subject Matter Experts providing training, as needed. Including, but not limited to: GMP Orientation, Train-the-Trainer (T3) and routine GMP training courses Create/revise and help others develop departmental SOPs, work instructions, training guides and checklists as needed; provide training to new system users/team members Process/Strategy Monitor the impact and effectiveness of learning solutions; evaluate learning programs & processes through LMS data, the development of surveys and other feedback mechanisms. Interpret data/feedback, discuss with stakeholders and/or Community of Practice (COP), and suggest improvements to further enhance learning program effectiveness and sustainability. Lead department/project meetings, track progress, ensure timelines are met and provide updates to team and management. Lead/Represent team in stakeholder meetings to ensure expectations are clearly defined, risks are appropriately managed and implications/change actions are communicated and executed. Develop business and project plans, communications and content to support business process and training activities. Quality Systems Support/perform Quality Systems operational activities including: LMS transactions, document review and processing, change controls, maintenance and generation of reports Monitor quality systems to drive completion of tasks, maintain compliance, identify quality system performance/process gaps, drive continuous improvement processes Manage/maintain file libraries, SharePoint, shared mailboxes and network drives for organization and access Provide support as SME for Training and/or Document Control systems during audits and inspections Support the development, collection and tabulation of metrics related to Quality Systems and processes Apply knowledge of internal systems or tools to provide relevant insights to metrics. Present Quality Systems topics and data at COP, Team Meetings, Quality Council, and other forums as requested by leadership. Ensure timely response to audit requests for quality systems data or documentation and/or serve in an audit support team role (e.g., document runner, ATMS, scribe, etc.) Support all quality system upgrade/validation/migration activities Serve as CAPA Owner and/or Change Control Author Supports and executes other activities as required by functional area management QualificationsEducation Bachelors Degree or equivalentRequired Experience: 4+ years of relevant experience. 2+ years work experience in pharmaceutical, consumer healthcare and/or biological manufacturing operation in Quality Assurance and/or Quality Systems. Experience with use of Quality Systems (e.g. document management, change control, training)Physical Demands: Lifting and/or carrying Knowledge, Skills and Abilities: Adult Learning: Experience in assessing competency gaps and identifying what people need to learn for successful individual and organizational performance. Advanced experience in developing and delivering training programs preferred. Knowledge of the applicable regulations including GxPs and working knowledge of other major regulatory agencies regulations and guidances preferred. Proficiency with MS Office, including Word, Excel and Power Point, Adobe, SharePoint and ability to learn new systems. Preferred Experience with use of document management and/or training systems (LMS) Experience using tools such as Captivate or Articulate to develop interactive learning Process Mapping/Improvement expertisePrimary LocationUnited States-Pennsylvania-Lancaster-OrganizationJohnson & Johnson Consumer Inc. (6101)Job FunctionHuman ResourcesRequisition ID2105898207W

Keywords: J&J Family of Companies, Lancaster , Quality Systems Specialist III, Other , Lancaster, Pennsylvania

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