Manufacturing Quality Supervisor

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Otsuka ICU Medical LLC in Austin is seeking a Manufacturing Quality Supervisor to ensure GMP-compliant operations. You will supervise exempt and non-exempt staff, oversee in-process monitoring, testing, and routine release of IV solution products at the Austin facility, and lead investigations and corrective actions.

The role requires coordinating quality programs, communicating across departments, and driving continuous improvement through SOP updates and CAPA activities; third shift Wed-Fri

Qualifications

• Bachelor’s degree in Chemistry, Engineering, Biology or Microbiology; 18+ years old.
• Minimum 2 years’ experience in Quality, Manufacturing, Engineering, or R&D in pharma/related industry.

Responsibilities

• Supervise MQ employees in in-process monitoring and testing.
• Ensure SOPs and GMP compliance; resolve issues.
• Lead investigations, ER/CAPA and prepare reports.
• Train staff and manage quality system projects.
• Coordinate with Operations, Materials, Engineering to resolve questions.
• Maintain quality through testing and statistical data analysis.

Skills

Parenteral manufacturing

GMP compliance

Regulatory requirements

Quality tools

Statistical quality control

Communication skills

Organizational skills

Education

Bachelor’s degree in Chemistry, Engineering, Biology or Microbiology

Job description

Position Summary

The MQ (Manufacturing Quality) Supervisor is responsible for ensuring manufacturing operations are operating under a state of GMP compliance. Supervise 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. In addition, when quality-related issues arise, the incumbent will investigate, document, and lead corrective actions to assure these are managed effectively. Coordinate, develop quality system programs and projects to ensure regulatory compliance, track and manage investigations per procedures. This individual must also effectively communicate in all directions, as part of this leadership role.

Job Description

The MQ (Manufacturing Quality) Supervisor is responsible for ensuring manufacturing operations are operating under a state of GMP compliance. Supervise 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. In addition, when quality-related issues arise, the incumbent will investigate, document, and lead corrective actions to assure these are managed effectively. Coordinate, develop quality system programs and projects to ensure regulatory compliance, track and manage investigations per procedures. This individual must also effectively communicate in all directions, as part of this leadership role.

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

Essential Duties & Responsibilities

• Supervise quality engineers and inspectors in a manufacturing environment.
• Provide supervision during the absence of the MQ Section Manager and in addition to the 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 Operation Procedures (SOPs) and GMP requirements. Pursues resolution of issues and problems as they arise.
• Interfaces with Operations, Materials Management, Engineering, and other various departments to resolve questions and/or determine if exception reports (ERs) are needed. Assist in the identification and resolution of potential manufacturing problems.
• Conducts ER/CAPA investigations as needed.
• Update Standard Operating Procedures as necessary and to address continuous improvement opportunities.
• Provide training and conduct verification assessments to ensure adequate maintenance of quality systems and processes, and manage projects to ensure completions within the required time schedule as required per quality systems.
• Prepare investigation reports/data as requested.
• Responsible for developing and executing goals and work plan for area responsibility. Maintain productivity reports.
• Ensures quality through testing and inspection at various stages of production process, and compiles and evaluates statistical data to determine and maintain quality and reliability.
• Conducts 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.
• Must have working knowledge of Good Manufacturing Practices and regulatory requirements. A working knowledge of Quality tools, such as statistical quality control.
• Communication skills (both written and verbal) with all levels of management are critical to the successful performance of this position.
• Strong 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 is required: Chemistry, Engineering, Biology, or Microbiology degree preferred.
• Minimum of 2 years’ experience in Quality, Manufacturing, Engineering, or R&D functions or any combination of the above, preferably in pharmaceutical, food or cosmetic industry is required.

Work Environment

• The MQ Supervisor role requires both manufacturing and office environment.
• This job operates in a professional office environment and routinely uses standard office equipment.
• While working in the manufacturing environment, there are high noise areas, areas where radiological hazards or lasers may be encountered and/or areas where biological hazards may be encountered.
• Occasional lifting up to 40 lbs. unassisted
• Typically requires travel less than 5% of the time

About Us

Innovation, Impact, and Purpose.
Find Your Future Here.
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.

EEO Statement

Otsuka ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [e-mail]. We are committed to providing equal access and opportunities for all candidates.
Otsuka ICU Medical EEO Policy Statement
Know Your Rights: Workplace Discrimination is Illegal Poster
Otsuka ICU Medical CCPA Notice to Job Applicants