Quality Systems Supervisor

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Main Responsibilities –

Working under general supervision, exercises direct supervision over the group responsible for records retention and Learning Management System (LMS) training and implementation, while adhering to department and company Detailed Work Instructions (DWIs) and Standard Operating Procedures (SOPs). Applies business knowledge and/or principles/methods normally acquired in a recognized four-year course of study or equivalent work experience. Trains and mentors subordinates and site personnel in the use and application of the company's LMS software, using practices that enable them to effectively perform their jobs within the multi-site organization. Promotes the process of continuous quality improvement and coordinates solutions for administrative and personnel issues. Troubleshoots complex problems. Exercises judgment in planning and organizing work; monitors performance and reports status. Responsible for the employment, training, motivation, counseling and discipline of employees supervised. Assists employees in understanding and compliance with Company policies and practices.

Process, index, archive and maintain proprietary information in accordance with Corporate, Division and Site policies and procedures to ensure compliance with FDA QSR, and ISO 13485. Serve as back-up for the administration and management of on-site document file storage which includes processing, indexing and archiving various forms of media such as paper, microfiche, diskettes and CD-ROM. Provide input and/or write department SOPs, policies and project plans for future training development and collection management. Provide customer-oriented services such as offsite storage database user assignment, record information review and retrieval requests. Respond to all clientele inquires in a timely, efficient and mutually agreeable manner. Work independently and as a team member in the successful completion of assigned goals. Physically capable of lifting records boxes, moving records folders, and operating high-density shelving several times a day.  Serve as the Offsite Storage liaison to Site Management Representative for FDA, TUV and corporate auditors. Comply with audit requests. Ensure that the retention database and records are audit ready at all times. Ensure processes and documentation are in place to satisfy on-site inspection and audit activities.  Ensure retention procedures and processes adhere to Corporate, Division and Site policies and procedures to ensure compliance with FDA QSR, and ISO 13485. Work with supervisor/manager and other departments to streamline processes, create efficiencies, and implement/complete special archiving projects. Answer queries from internal staff on indexing, procedures, and questions relating to record retention and retention database functionalities. Conduct periodic reviews of Quality System documents, compile reports and submit to various department/document owners.

Job Responsibilities –

• Ensures staff is appropriately trained in processes and procedures related to LMS; ensures established processes and procedures are being followed and documented. Accountable for the performance of subordinates and work output of managed subcontractors. Maintains a safe work environment and a strong customer focus.
• Create Detailed Work Instructions (DWIs) pertaining to record retention, LMS and training processes.
• Partner with company managers, internal and external developers, course owners and other stakeholders to ensure effective administration of the LMS. Maintain open communication and build strong relationships to successfully execute role.
• Launch new courses within the LMS, build associated learning activities, audiences, and properties; execute proper testing protocols consistently to ensure flawless implementation.
• Review/audit and rebuild existing course structures, audiences, and curricula for improved functionality. Schedule ongoing reviews to ensure all course content is active and in good working order.
• Develop new and revise existing courses on request, working in conjunction with managers to ensure quality and timeliness of content.
• Provide technical information concerning related systems, applications, institutional standards, requirements, objectives, and policies and procedures. Troubleshoot all system issues through to satisfactory resolution.
• Maintain updated documentation such as issue tracking log, master course catalog, training request forms, development guidelines and user manuals relevant to LMS.
• Develop and implement training programs for LMS users ensuring complete knowledge of system. Responsible for overall quality control of both system and content.

• Develop, produce, and distribute reports based on LMS data for management and/or audit use.
• Define and allocate resources needed to meet established project schedules.
• Establish functional goals, strategies, and tactics to assure optimal customer service.
• Aid in the preparation of budgets as related to training, personnel, and training records.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Evaluates quality process and system standards to ensure compliance with standards and regulatory requirements
• Write and/or update system procedures for LMS management system
• Be able to communicate verbally and in writing to cross functional teams
• Windchill expertise….
• Troubleshoot system issues and communicate to management suggested fixes……
• Communicate business priorities to ensure projects are managed to meet business goals
• Support and monitor the analysis and resolution of complex Records Management problems
• Coordinate implementation of records storage with all affected sites/areas
• Ensure storage practices are documented and in compliance with regulations
• Work with departmental representatives to review materials and gain approval for destruction of records
• Write and/or update system procedures for Records Retention
• Provide training and coaching to specialists when updates are……
• Support all Internal, External and FDA audits
• Process, index, archive and maintain proprietary information stored offsite. Participate in on going Collection Development initiatives.  Conduct periodic review of Quality System documentation and disperse report to affected Document Owners.

Qualification -

Education Level Major/Field of Study Or Education Level

Associates Degree (± 13 years) Business Administration or a related field, or an equivalent combination of education and work experience

Experience Details

Minimum 4 years: Progressively more responsible experience using such applications as LMS, Microsoft Office Suite, as well as a working knowledge in Adobe Flash, Photoshop, HTML, Captivate, SharePoint, Articulate, or the equivalent is required.

Experience with LMS or other training software management or use.  Must be able to demonstrate and use discretion in exercising work assignments and handle sensitive/confidential information in an effective manner. Must be able to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and company operating procedures, processes, policies, and rules. Must have demonstrated personal computer skills including a working familiarity with relevant training, database, and spreadsheet applications and specialized applications that support the site’s training processes.

Experience working in a broader enterprise/cross division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner.

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