Manufacturing Quality Supervisor

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

Job summary

Otsuka ICU Medical LLC is seeking a Manufacturing Quality Supervisor to ensure GMP-compliant operations at our Austin facility. You will supervise quality engineers and inspectors, manage in-process monitoring, testing, and product release, and lead investigations and CAPAs when issues arise.

The role requires strong knowledge of GMP, quality systems, and effective cross-functional communication; 3rd shift is Wednesday-Friday and every other Saturday from 6:00pm to 6:00am, with travel minimal.

Qualifications

• Bachelor's degree required in Chemistry, Engineering, Biology, or Microbiology.
• Minimum 2 years in Quality, Manufacturing, Engineering, or R&D in pharma/related industries preferred.
• Strong knowledge of GMP and regulatory requirements essential.

Responsibilities

• Supervise quality engineers and inspectors in a manufacturing environment.
• Lead investigations and CAPA activities; prepare inspection and batch-review documents.
• Ensure SOP compliance and GMP adherence across production and QA activities.
• Collaborate with Operations, Materials, Engineering and other departments to resolve issues.

Skills

GMP knowledge

Quality investigations

Leadership

Analytical thinking

Education

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

Tools

Statistical quality control

Job description

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. 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 UsInnovation, 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.

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