Subject Matter Expert (SME) and System Administrator with responsibility for the management and oversight of Management Review, Post Donation Information (PDI), CAPA, Deviations, and Integration. Ensures all areas of responsibility are adhering to procedures and requirements. Responsible for handling multiple tasks, projects, and ensuring commitments are completed on-time. Demonstrate effectiveness in task completion, decision-making, empowering others, training, and problem solving. Lead DMAIC, QWT, Kaizen or equivalent focus type group activities. Compile, review, and present statistical data for key quality indicators and metrics. Prioritize work assignments and complete essential duties. Notify management of any issues that could jeopardize the effective release of acceptable Product to internal and external customers. Essential Duties and Responsibilities
- Manage activities to achieve defined quality and department goals in an efficient, accurate, and timely manner.
- Performing required tasks associated with company procedures, government regulations, and guidelines to maintain compliance.
- Interface with division, quality, manufacturing, and technical support groups to resolve issues related to Quality Systems.Provide innovative solutions and drive continuous improvement initiatives in the areas of Change Control, Complaint Handling, PDI, Site Master File, and Product Hold management for compliance to internal/external quality and customer requirements.
- Compiles and review system requirements and documentation is complete (e.g. checklists, logs, binders, etc.), accurate, and in compliance with internal/external quality and customer requirements.
- Perform Product impact assessments for PDI/Events to determine if additional action is needed (e.g. customer of intermediates notification, BPDN, FCA evaluation, etc.) and facilitate timely release of Product Holds.
- Provide oversight and/or directly manage complaints per applicable procedures.Mentor complaint investigators and owners to ensure all requirements are met.
- Grant system access to trained individuals.Lead in the development of customer training, awareness, and understanding of activities for areas of direct responsibility throughout the facility.
- Ensure proper maintenance and data integrity of the various databases, which relate to quality operations.
- Obtain feedback and input from quality and manufacturing functions to define user requirements for systems utilized to manage Complaints, SMF and Product Holds (e.g. TrackWise).
- Responsible for compiling and/or reviewing various key quality indicator trend / metric data at defined frequencies.Presentation of trend and metric data via Management Review mechanisms.
- Monitor Complaint systems to ensure timely, appropriate, and thorough resolution of issues and closure of records.Identify and recommend when escalation is needed.
- Perform process audits to ensure departmental procedures are consistent with business and regulatory requirements.Revise department owned procedures through manual or electronic documentation change control, as needed to meet internal/external quality requirements.
- Assist with audit ready status efforts of assigned areas.Assist other areas within the facility in understanding quality requirements. Maintain a high level of expertise in internal/external quality requirements, and serve as a facility resource for compliance to requirements.
- Ensure staff is 100% trained and qualified to perform essential duties.Provide coaching, guidance, and development to staff and less experienced individuals within the facility.
- Provide guidance and assist users with Complaint/Change Control systems workflow management.Create queries, Ad Hoc reports, and data export templates for user and management visibility of Quality Systems records.
- Complete other tasks as assigned by management.
Qualifications Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices. Education and/or experience
- A minimum of 3 to 5 years of experience in the pharmaceutical industry and a minimum of 3 years in Quality related roles with Quality System experience being highly desirable. BA/BS degree in Engineering, Science or related fields.
• Must be able to lift, push, pull and carry up to 20 lbs.
• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility. Working Environment
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will work in a cold, wet environment
• Must be able to work multiple shifts, including weekends.
• Must be able to work overtime as required. (only for non-exempt positions)
• May be required to work in a confined area.
• Some Clean Room and cool/hot storage conditions.
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.