Assistant Quality Control Manager

Swiss American CDMO • Carrollton, TX

1d • Onsite

About The Position

The Assistant Quality Control Manager supports the day-to-day management of Quality Control operations and personnel in a regulated manufacturing environment. This role is responsible for helping ensure compliance with company procedures, GMP requirements, and regulatory standards while supporting raw material inspection, environmental monitoring, investigations, CAPA activities, and continuous improvement initiatives.

Requirements

• Experience in Quality Control, Quality Assurance, or a related manufacturing environment.
• Knowledge of GMP, FDA regulations, quality systems, and audit processes.
• Strong analytical, problem-solving, organizational, and communication skills.
• Ability to manage multiple priorities and work effectively across departments.

Nice To Haves

• Bachelor's degree in a related field preferred.
• Prior leadership or supervisory experience preferred.

Responsibilities

• Assist in leading a Quality Control team of 15+ employees, including supervisors and quality associates.
• Oversee raw material receiving, inspection, release activities, and nonconforming material investigations.
• Support environmental monitoring, water sampling, temperature monitoring, and dose audit programs.
• Coordinate testing activities with third-party laboratories and ensure timely follow-up of results.
• Investigate quality events, process deviations, and product quality issues and assist with corrective actions.
• Support CAPA development, implementation, and effectiveness reviews.
• Ensure compliance with SOPs, FDA regulations, GMP requirements, and internal quality standards.
• Monitor Quality Management System (QMS) activities and identify opportunities for continuous improvement.
• Assist with KPI reporting, employee scheduling, performance management, and audit readiness activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level