Manufacturing Supervisor IIReq # JR - 025149 Location Bloomington, Indiana, United States Additional Locations 40 Job Category Manufacturing Date posted 07/30/2020
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The Supervisor II, Manufacturing is a member of the Manufacturing Leadership Team and reports directly to the Manufacturing Manager. He or she provides direct support to Manufacturing personnel. The Supervisor II, Manufacturing provides decision making and oversight to ensure compliance to all standard operating procedures and batch records. He or she must communicate effectively with manufacturing support departments (Quality, Technical Services, Engineering, etc.), multiple levels of management, and other customer support departments. The Supervisor II, Manufacturing creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. This position reports to a Manager II, Manufacturing.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned)
- Understand and follow current Good Manufacturing Practices
- Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
- Interview, hire, coach, and develop staff. Conduct annual performance reviews for all direct reports. Assists in setting performance objectives and development plans.
- Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities – to meet customer requirements including deadlines and quality standards. High percentage of Gemba (shop floor) presence.
- Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
- Implement and support training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs and EHS regulations.
- Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments.
- Lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.
- Resolve technical, material and cGMP problems that may impact project deadlines.
- Provide guidance and troubleshooting assistance as needed during a deviation in the process; utilizing Root Cause Analysis (RCA) tools when applicable.
- Obtain qualification to perform select critical operation processes.
- Represent the company during audits and inspections.
- Author Non-conformance investigation reports (NCRs).
Job Requirements (Education, Experience and Qualifications)
- Bachelor’s degree required
- Minimum 3 years of manufacturing experience required
- Minimum 4 years supervisory related experience required
- In-depth process knowledge of related manufacturing equipment and processes preferred
- Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, SCADA (or similar) system, etc.)
Physical / Safety Requirements
- Ability to stand or sit for extended periods of time
- Ability to lift up to 50 pounds
- Ability to push/pull heavy wheeled objects (ie: tanks, carts, pallet jacks, etc.)
- Must be able to perform overhead work (ie: sanitizing walls and ceilings)
- Physical coordination/flexibility to allow gowning for clean room environments
- Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
- Dexterity and physical condition to perform some level of repetitive motion tasks
- Ability to wear respirator usage when product or task requires
- Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable)
- Use of hands and fingers to manipulate office equipment is required
- Must be able to gown qualify for Grade A/B areas (filling)
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.