Supervisor QA Process

Responsibilities

• Provide direct supervision to a team of QA associates on the 3rd shift
• Oversee daily operations of the Process Quality team to ensure manufacturing support
• Manage the development, implementation, and maintenance of Quality Assurance systems
• Review and approve GMP documents and minor deviations through the document management system
• Perform investigations associated with Quality Operations and provide quality oversight for manufacturing processes
• Review and approve certificates of analysis for raw materials
• Identify training needs, develop competency-based training materials, and manage employee performance documentation
• Supervise material/labeling sampling, finished product inspection, and cleaning of inspection areas
• Provide KPI data for "Right the First Time" metrics

Requirements

• High school diploma or GED required
• 6+ years of experience in pharmaceutical or medical device Quality Assurance
• Strong knowledge of cGMP and ISO 13485 standards
• Proven skills in procedure writing and effective oral/written communication
• Ability to work the 3rd shift schedule (Sunday - Wednesday, 5:00 pm - 5:30 am)

Preferred Qualifications

• Bachelor’s degree in a scientific discipline or a related field

About the Company

Tolmar is a pharmaceutical company dedicated to positively impacting lives through high-quality products. We operate under core values of being people-centered, proactive, ethical, constantly improving, and accountable.