Quality Assurance Supervisor

• Act as the site's Quality and Compliance Leader, and when necessary, as the site's Designated Management Representative to ensure compliance with all regulatory, corporate and facility requirements.
• Ensure outstanding Quality System performance via monitoring and measuring of process performance, and driving any appropriate action, including issuing and follow-up on activities required for sourcing, warehousing, and distributing pharmaceuticals.
• Reviews and monitors Quality metrics and reports trends, to determine if there is a need to escalate issues to the management.
• Perform, review and monitor the Quality Management processes which includes but is not limited to:

• Ensure compliance with FDA, DEA and BOP requirements, including DSCSA traceability of pharmaceuticals.
• Oversee Regulatory activities associated with distribution licensing, drug distribution reports, and permits for warehousing and distribution of controlled substances.
• inspection and product release, label approval, calibration, warehousing controls, record retention, document control, training, control of non-conforming product, quarantined Products, control of access and drugs storage, including temperature monitoring.
• Host and manage internal and external audits. Ensure the site's readiness for assessments and lead implementation of corrective actions.
• Effectively assess processes and identify opportunities for improvement.
• Review, Analyze and Report Statistical findings through critical thought and storytelling of key findings and opportunities to all levels within a matrixed organization.
• Partner with other departments to identify critical to quality metrics, and support the operationalization of monitoring and management to deliver improved performance across processes.
• Create effective and compelling visual materials/presentations that support the process/product improvement impact to the organization and adequately represent the impact to quality, cost and time.
• Define, track, and monitor key success measures associated with Quality Management Systems. Successfully deploy and support change management and appropriate training plans.

• Manage document control functions, including creation, review, and approval of procedures, work instructions and all other documentation for the Quality System.
• Manage the complaint handling system, including trending and review to identify opportunities for improvement.
• Manage the training of the Site, by maintaining the training log, tracking training completion of training by site personnel, creating training content and hosting group training as needed.
• Develop and host the Quarterly Management Review
• Manage the Recall process, from notification, tracking responses & expenses, reporting, and closure.
• Develop, refine, and/or maintain quality standards, policies, and procedures for the facility, including identifying, recommending, and fully implementing changes, in partnership with corporate QRA and local operations teams.
• Supervise Quality Associates

• Take a lead role in internal/external Audit Program.
• Perform Quality Department tasks as the functional back-up.
• Assis with other assigned tasks.

• Associate's degree (or above).
• 2 years of relevant experience in a medical device or pharmaceutical company.

• Previous experience as a lead or supervisor

• Proficient in Microsoft Office Suite (Excel, Power Point, Word and Outlook, Project, Statistical Tools)
• Strong attention to detail.
• Excellent leadership skills.
• Ability to work in a team environment as well as alone with little direction.

• Excellent verbal and written communication skills to all levels of the organization.
• Strong organizational, prioritization, and problem solving skills required.

Young Innovations