Manufacturing Quality Supervisor

Position Summary

The MQ (Manufacturing Quality) Supervisor is responsible for ensuring manufacturing operations are operating under a state of GMP compliance. The role supervises the daily activities of exempt and non‑exempt personnel involved in in‑process monitoring, testing/sampling, quality evaluation and routine release of products manufactured at the Austin facility. When quality‑related issues arise, the incumbent investigates, documents, and leads corrective actions to assure effective management. The supervisor also coordinates and develops quality system programs and projects to ensure regulatory compliance, tracks and manages investigations per procedures, and communicates effectively in all directions as part of this leadership role.

Essential Duties & Responsibilities

• Supervise quality engineers and inspectors in a manufacturing environment.
• Provide supervision during the absence of the MQ Section Manager and on off‑shifts.
• Hire, train, supervise, evaluate, and develop MQ employees to perform in‑process monitoring of production processes related to Intravenous Solution manufacture.
• Monitor manufacturing processes and personnel to assure compliance with Standard Operating Procedures (SOPs) and GMP requirements.
• Pursue resolution of issues and problems as they arise.
• Interface with Operations, Materials Management, Engineering, and other departments to resolve questions and determine if exception reports (ERs) are needed.
• Assist in the identification and resolution of potential manufacturing problems.
• Conduct ER/CAPA investigations as needed.
• Update Standard Operating Procedures to address continuous‑improvement opportunities.
• Provide training and conduct verification assessments to ensure adequate maintenance of quality systems and processes; manage projects to ensure timely completion.
• Prepare investigation reports and data as requested.
• Develop and execute goals and work plans for area responsibility; maintain productivity reports.
• Ensure quality through testing and inspection at various stages of the production process; compile and evaluate statistical data to maintain quality and reliability.
• Conduct batch record reviews, author re‑inspection plans, and provide quality oversight during re‑inspections to assure samples are within specification limits.
• Partner with manufacturing to track and trend metrics and assist with continuous improvement.
• Perform other related duties as assigned or required.

Knowledge & Skills

• Knowledge of parenteral manufacturing preferred.
• Working knowledge of Good Manufacturing Practices and regulatory requirements.
• Familiarity with quality tools such as statistical quality control.
• Strong written and verbal communication skills with all levels of management.
• Excellent organizational skills and ability to write clear investigative reports.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age.
• Bachelor’s degree from an accredited college or university required; Chemistry, Engineering, Biology, or Microbiology degree preferred.
• Minimum of 2 years’ experience in Quality, Manufacturing, Engineering, or R&D functions (or any combination thereof), preferably in the pharmaceutical, food, or cosmetic industry.

Work Environment

The MQ Supervisor role involves both manufacturing and office environments. The position operates in a professional office setting with standard office equipment. In the manufacturing area, there are high‑noise zones, potential radiological or laser hazards, and possible biological hazards. Occasional lifting of up to 40 lb unassisted may be required. Travel is typically less than 5 % of the time.

Schedule

3rd shift: Wednesday – Friday and every other Saturday (6:00 pm – 6:00 am).

About Us

Innovation, impact, and purpose drive our work. We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption. When you work here, you become part of something bigger—a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide. We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters. Join us and help shape the future of IV solutions.