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Manufacturing Operations Manager
2 months ago
We are seeking a highly skilled Manufacturing Supervisor II to join our team at Baxter. As a key member of our production team, you will be responsible for overseeing daily activities in the production area to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (cGMPs), SOPs, environmental health and safety (EHS) guidelines and any other regulations that may apply.
Key Responsibilities- Supervise and insure efficiency and effectiveness in various areas, ensuring operational efficiency, troubleshooting and investigating as necessary.
- Perform all duties with a focus on optimizing safety, quality, service and cost.
- May supervise more than one department.
- Communicates guidance, support, direction and leadership through effective interactions with all personnel during daily operations.
- Reviews, approves, and leads documentation for batch and system records, assists in release of product for distribution, and assists in meeting product release time goals.
- Identifies, initiates and facilitates continuous improvements, lean manufacturing activities and initiatives, such as 5S, visual management, kaizens.
- Ensures resources and raw materials are utilized in the most efficient and productive manner possible.
- Develops training content and facilitates and verifies appropriate training for employees in the area.
- Ensures compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements as required.
- Submits and/or maintains and distributes reports related to attendance, labor, efficiency, safety, scrap and others as needed.
- Performs/leads technical reviews, investigations and process improvement projects.
- Provides manufacturing input into integration and validation of new equipment and processes.
- Resolves technical, material and cGMP problems that may impact project deadlines, provides guidance and troubleshooting assistance as needed during a deviation in the process.
- May represent the company during FDA inspections or provide information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs.
- May monitor capital expenditures and assist in developing budgets.
- Bachelor's degree preferred; minimum Associates degree with technical discipline required.
- And/or 3 years manufacturing experience and 2 years of supervisory experience.
- Consistent track record of interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment.
- In-depth process knowledge of related manufacturing equipment and processes.
- Ability to lead multiple priorities in a manufacturing plant setting.
- Ability to analyze and interpret scientific and statistical data.
- Strong professional writing skills and ability to prepare technical reports. Ability to clearly articulate information during regulatory/client inspections.
- Ability to understand GMPs and other applicable regulatory guidelines.
- Strong assessment and troubleshooting skills.
- Ability to respond to detailed inquiries and present information to groups and senior leaders.
- Ability to supervise multiple groups/shifts, if applicable.
- Computer proficiency in Microsoft Office and ability to use enterprise software.
- Ability to collect and analyze data and information to resolve paths for process improvement and potential root cause.
- Ability to respond to detailed inquiries and present information to groups and senior leaders.
- Demonstrated critical thinking and problem-solving skills.
- Solid understanding of manufacturing business acumen.
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