Manufacturing Supervisor, Extrusion CompoundingReq # JR - 048555 Location Irvine, California, United States Job Category Manufacturing Date posted 09/21/2021
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Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
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Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
The Manufacturing Supervisor implements and supervises all activities in the extrusion compounding manufacturing area. Ensuring manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines and any other applicable regulations. Monitor and ensure efficiency and effectiveness across 2 shifts of the manufacturing process. Perform all duties with a focus on optimizing safety, quality, service, and cost. May monitor and control labor and capital expenditures. May assist in developing budgets. Recommends manufacturing policies, procedures, and programs.
Essential Duties and Responsibilities
Compounding & Extrusion Supervisor – Specific duties include:
- Serve as technical subject matter expert for the Compounding, Screening, and Extrusion processes for both 1st and 2nd Shifts.
- Manages compounding and extrusion production schedule to ensure adequate inventory levels.
- Lead initiatives to improve bladder quality, increase efficiency, reduce conversion loss, and reduce customer complaints.
- Serve as backup for the General Manufacturing Supervisors, as required for both 1st and 2nd shifts.
- Communicates guidance, support, direction and leadership through effective interactions with all personnel during daily operations.
General Production Supervisor – Specific duties include:
- Supervise the day-to-day production, employee scheduling, staffing, material management in the manufacturing area, compliance, training, and auditing activities.
- Interviews, hires, coaches, motivates, develops, recognizes, and manages performance of direct reports. Provides regular feedback to all direct reports. Assist in setting performance objectives, development plans, and monitoring employee performance progress.
- Ensures adequate personal protective equipment is in place and properly used to maintain a safe working environment.
- Learn, understand, revise, and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP).
- Works closely with Maintenance Supervisor to set up the right procedures and activities to assure world class equipment availability indicators and a clean and safety environment.
- Perform technical reviews, investigations, and process improvement projects. Resolves technical, quality, material, and cGMP problems that may impact production targets. Provide guidance and troubleshooting assistance as needed during a deviation in the process
- Establish systems, metrics, leader standard work, and controls for the execution of manufacturing activities such as productivity (efficiency, scrap, labor, resources, schedule adherence), quality (defects, exceptions, complaints) and human resources (motivation, absenteeism, interpersonal conflicts, people development). Escalates issues to appropriate leadership when issues arise to ensure swift resolution.
- Leads initiatives to maintain a continues improvement environment around the manufacturing operations by implementing and innovating with six sigma, lean manufacturing, VSM’s, 6s, and any other philosophies that will reduce waste, increase productivity, quality, and safety. This role may also be responsible for identifying and implementing Value Improvement Projects (VIPs).
- Monitor capital expenditures and assist in developing budgets.
- Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
- Serve as manufacturing representative for change control process (change control assessments and action owner).
- Provide manufacturing input into integration and validation of new equipment and processes.
- Represent the company during FDA inspections. Provide information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs.
- Supervise training programs for the Manufacturing team designed to enable manufacturing employees to consistently execute all manufacturing processes with strict compliance to cGMPs and EHS regulations.
- Demonstrated interpersonal and leadership skills with ability to interface well with other departments and lead effectively and efficiently in a team environment.
- Ability to manage multiple priorities in a manufacturing plant setting.
- Ability to analyze and interpret scientific, and statistical data.
- Ability to collect and analyze data and information to determine paths for process improvement and potential root cause/corrective actions in the case of exceptions.
- Ability to supervise multiple groups/shifts.
- Strong professional writing skills and ability to prepare technical reports.
- Strong assessment and troubleshooting skills.
- Strong computer proficiency in Microsoft Office and ability to use enterprise software.
- Strong ability to respond to detailed inquiries, and present information to groups and senior management.
- Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
- Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
- Must have strong English written and oral communication skills adequate to communicate with other team members.
- Compounding & Extrusion Supervisor – Strong decision making and problem-solving skills (specifically with highly specialized and technical machine production processes and/or heavy machinery)
Education and/or Experience
- BS degree in a scientific or engineering discipline with 3 or more years of extrusion compounding manufacturing experience. Compounding & Extrusion SME – Experience running or supervising compounding and/or extrusion process (or equivalent).
- Plus 4 or more years progression in supervisory related experiences preferred
- Lean manufacturing and/or 6 sigma certification or experience preferred.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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