Description

Site Overview:

PuraGraft represents the leading manufacturers of biomaterial solutions for bone and tissue regeneration. No single material can suit all medical requirements and indications. However, through PuraGraft you have access to the widest choices of products. 

Role Overview:

Reporting to the QRA Manager for Young Innovations, the Quality Assurance Supervisor will be tasked with ensuring Quality standards are met or exceeded in all facets of the operation. He/she will partner internally in the development and implementation of new or adjusted quality standards, policies, and procedures, as required.

• 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

RELATED DUTIES:

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

Qualifications

MINIMUM QUALIFICATIONS:

Training and Experience:

• Associate’s degree (or above).
• 2 years of relevant experience in a medical device or pharmaceutical company.
  • Previous experience as a lead or supervisor

Knowledge, Abilities and Skills:

• 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.

PHYSICAL REQUIREMENTS:

The position requires the ability to sit, stand, stoop, bend, and walk frequently during the shift. The position may require working extended hours or on weekends as needed. Incumbent may need to lift up to 30 lbs. on occasion.

Working Conditions:

Office and warehouse environment, with some normal variations in temperature.

Travel less than 5%.

Pay Range: $70,000 - $90,000/yr.

The pay range reflects the minimum and maximum target for the position at the time of posting. Within the range, the compensation will be determined based on education/training, skill set, experience, and other organizational needs.

Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer