Manufacturing Supervisor IIReq # JR - 024206 Location Hayward, California, United States Job Category Manufacturing Date posted 07/09/2020
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The Supervisor II position is responsible for providing supervision and implementation of all activities within the manufacturing area to ensure goals and project deadlines are met with a maximum and efficient use of staff and materials as well as strict adherence to cGMP, environmental health and safety guidelines and any other related regulations which could apply.
- Supervisor is expected to provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
- Responsible for supervising the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities and to meet customer requirements including deadlines and quality standards.
- Interview, hire, coach, motivate, develop and discipline staff. Conduct annual performance reviews for all direct reports. Assist in setting performance objectives and development plans. Monitor progress.
- Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
- Emphasize 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.
- Perform/lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.
- Resolves technical, material and cGMP problems that may impact project deadlines. Provide guidance and troubleshooting assistance as needed during a deviation in the process.
- Represent the company during FDA inspections. Provide information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs. 10) Provide a positive and equitable working environment emphasizing the Baxter Shared Values: Respect /Responsiveness / Results.
- Demonstrated 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 manage 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.
- Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
- Strong assessment and troubleshooting skills.
- Ability to respond to detailed inquiries, and present information to groups and senior management.
- May be required to supervise multiple groups/shifts.
- Overtime may be required at times.
- Good computer skills.
- BS degree in a scientific or engineering discipline with 3-5 years of manufacturing experience or AA degree or equivalent manufacturing experience. Plus 4-6 years supervisory related experience required.
- Regular attendance is necessary to perform the essential functions of the job.
- Light work, frequent lifting up to 10 lbs; frequent standing/walking/gowning is required.
- Frequently gowns into an Iso Class 7 and 8 cleanroom environments.
- Hazards that the incumbent may work with are: alcohol, acids, sodium hydroxide, cyanogen bromide, buffers, etc.
- Minimal travel required.
- Normal office and cleanroom working conditions: computer, phone, files, fax, copier, cleanroom
- Personal Protective Equipment:safety glasses, gloves, hearing protection, surgical mask, safety shoes as required
- Will work in controlled environment that requires special gowning and protective clothing over the head, face, hands, feet, and body.
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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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.