Aegis Worldwide

Quality Control Supervisor

3rd SHIFT/$90-$110k/Full-Time

Carmel, IN

Overview:

Aegis is currently partnered with a bio medical manufacturer.

Responsibilities

• Ensure compliance with all applicable US and international regulatory standards including FDA, EU, ISO, USP, NRC, and cGMP guidelines.
• Coordinate cross-functionally to align QC testing schedules with production plans and ensure all testing and maintenance activities are completed on time.
• Perform and oversee testing of finished product, raw materials, components, stability samples, validation batches, and experimental samples.
• Review, approve, and maintain controlled documents within area of responsibility.
• Lead and support investigations related to deviations, product failures, and customer complaints. Author and review quality and safety reports and drive timely corrective actions.
• Ensure safe handling of radioactive materials and maintain exposure levels As Low As Reasonably Achievable (ALARA).
• Coach, develop, and manage team performance while aligning goals with site objectives and KPIs. Conduct daily huddles and communicate performance metrics.
• Manage department overtime, maintain 5S standards, and ensure training and qualification compliance.

Requirements

• Bachelor’s degree in Chemistry, Science, or related field required. Relevant experience may be considered in lieu of degree.
• 10+ years of relevant experience required with prior supervisory experience preferred.
• Strong knowledge of cGMP laboratory operations and major laboratory instrumentation.
• Ability to interpret laboratory data and make sound compliance decisions.
• Proven leadership, communication, coaching, and conflict management skills.
• Strong analytical, problem-solving, and decision-making abilities with capacity to manage multiple priorities.
• Ability to work in a radioactive manufacturing environment and meet physical demands including lifting up to 70 pounds, wearing PPE, standing for extended periods, and working off-shift, weekends, or holidays as needed.