Supervisor, Quality Control

Role Summary

Supervisor, Quality Control at MannKind. Responsible for developing, implementing and maintaining quality control systems, overseeing inspection, testing and evaluation of products to ensure conformity with quality specifications and GMP standards.

Responsibilities

• Provide general or direct supervision to exempt and/or skilled nonexempt employees
• Act as advisor to units to meet schedules or resolve problems
• Supervise on the floor enforcing data integrity, SOPs, specifications, methods, USP, and cGMP through real-time verifications of records and related documents
• Troubleshoot methods, instrumentation, and execution of tests to assist analysts
• Schedule testing/review of raw materials, in-process, finished product, stability samples, complaint samples, and samples from process and cleaning validation activities
• Exercise judgment within defined procedures to determine appropriate action; review data for anomalies or trends and approve data
• Lead and approve investigations of suspect or out-of-spec results with CAPA implementation
• May perform bench analysis as needed
• Interact with subordinates, external customers, and cross-functional teams at various management levels
• Present technical information on projects/schedules; contribute to cross-functional projects with significant impact
• Observe all Company, Health, Safety and Environmental guidelines
• Additional duties as assigned

Qualifications

• BS in a scientific discipline with 5+ years‚Äô experience or MS with 3+ years, or equivalent combination
• Experience with HPLC
• Empower experience
• Proficiency in MS Word, Excel, and PowerPoint
• Strong interpersonal and organizational skills
• Supervisory experience

Skills

• Quality control systems management
• Regulatory compliance (FDA, ISO 13485/9001, European requirements)
• Data integrity and GMP practices
• Problem solving and CAPA development
• Communication and collaboration across functions

Education

• BS in a scientific discipline or higher

Additional Requirements

• Travel not specified