Manufacturing Quality Supervisor

Otsuka ICU Medical•Austin, TX

6d•Hybrid

About The Position

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)

Requirements

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.
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.

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.