Quality Control Manager

Aegis Worldwide; Carmel (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Aegis Worldwide is seeking a Quality Assurance Manager to oversee timely testing and notification of abnormal materials that could affect manufactured products. The role ensures QC testing compliance, maintains test specifications for raw materials and components, and plans laboratory activities in line with site strategies.

The ideal candidate brings 10+ years in quality control, strong leadership, and extensive HPLC experience, with a Bachelor's degree in a related field.

Qualifications

• Bachelor's degree in chemistry, science, or related field preferred.
• 10+ years of quality control experience in a lab setting.
• 2+ years of experience managing processes or people in QC.
• Extensive experience with HPLC.

Responsibilities

• Support investigations into product or process failures and customer complaints, author and review quality and safety reports and investigation findings.
• Drive timely completion of corrective actions within the area.
• Ensure safe handling of radioactive materials and maintain exposure levels per ALARA principles.
• Mentor and develop team members to achieve high performance with accountability.
• Align team goals with site strategies and manage individual performance.
• Maintain compliance with U.S. and international regulatory standards and guidelines.
• Coordinate testing schedules and communication across functions; support weekly production; ensure QC testing and maintenance meet requirements.
• Plan and oversee testing for production samples, raw materials, components, stability studies, validation activities, and experimental/protocol samples.
• Review, verify, and update controlled documents related to the area of responsibility.

Skills

Quality control leadership

Lab experience

HPLC

People management

Investigations

Corrective actions

Regulatory compliance

Schedule testing

Documentation control

Education

Bachelor's degree in chemistry/science/related field

Tools

HPLC

Job description

This role ensures timely testing and notification of any abnormal occurrences that could negatively affect manufactured products. The Manager oversees and maintains quality programs to ensure that all test specifications are met for raw materials, components, and validation testing. This position is responsible for scheduling laboratory testing, and implementing corrective actions.

Must Haves:

• Bachelor's degree in chemistry, science, or related field highly preferred
• 10+ years of quality control experience in a lab setting
• 2+ years of experience managing processes or people in a quality control setting
• Extensive experience with HPLC

Job Responsibilities:

• Support investigations into product or process failures and customer complaints, author and review quality and safety reports and investigation findings.
• Drive timely completion of all assigned corrective actions within the area.
• Ensure safe handling of radioactive materials and maintain team exposure levels in line with As Low As Reasonably Achievable principles.
• Mentor and develop team members to achieve high performance while promoting accountability and team ownership; recognize and reward strong performance.
• Establish clear direction by aligning team goals with site strategies and actively managing individual performance.
• Maintain compliance with U.S. and international regulatory standards and guidelines.
• Collaborate cross-functionally to coordinate testing schedules and communication, supporting weekly production and ensuring QC testing and maintenance meet requirements.
• Plan and oversee testing for production samples, raw materials, components, stability studies, validation activities, and experimental/protocol samples.
• Review, verify, and update controlled documents related to the area of responsibility as needed.