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- Candidate must not be allergic to penicillin or cephalosporins
Summary
Responsible for manufacturing and assembly of products. Operates production equipment. Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities. Maintains records and clean room environment to comply with regulatory requirements, good manufacturing practices and standard operating procedures. May assist with in-process testing to ensure batches meet specifications. Responsible for executing all processes in production while strictly adhering to cGMP, SOPs, environmental health and safety guidelines and any other related regulations which could apply. Expected to fully participate in both departmental projects and work teams as appropriate. May troubleshoot equipment, train others, assist in reviewing batch records, participate in continuous improvement teams, perform complex trouble shooting tasks and recommend changes to SOPs or procedures. Acts as a delegate to the supervisor and may conduct departmental activities in their absence. Generates/closes work orders and performs preventive maintenance.
- Assists supervisor in organizing, scheduling and directing other team members.
- Acts as main interface with other departments to resolve issues related to equipment, process, compliance, including maintenance, metrology, validation.
- Involved in hands-on execution of manufacturing operations.
- Resolves issues related to equipment, process and compliance. Main point of contact for troubleshooting.
- Ensures timely and accurate generation of process documentation. Review documentation.
- Investigates any process problems timely and provide documentation.
- Assists with process/equipment validation and data analysis.
- Represents the department in cross-functional teams and Continuous Improvement Teams and assigns project work to team members.
- Trains and mentors other team members and monitors training by others.
- Assigns tasks and develops work schedule.
Qualifications
- Must have good written and verbal communication skills and be able to read and follow detailed written instructions.
- Must have demonstrated interpersonal and leadership skills and the ability to lead a work team effectively and efficiently in a team environment.
- The incumbent must work in a clean room environment wearing special garments and personal protective equipment must be worn due to safety requirements.
- Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
- Familiarity with production equipment.
- Must be able to apply quantitative analysis to analyze process performance.
- In-depth process knowledge of related manufacturing techniques and specialties.
- Computer proficiency and ability to use enterprise software.
- Must meet local physical requirements.
- Knowledge of basic chemical and biological safety procedures preferred.
- Understanding of cGMP regulations preferred.
- Candidate must not be allergic to penicillin or cephalosporins
Education
- High school diploma or equivalent with 3 years’ experience. Bachelor's degree (with reduced years of 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.
EEO is the Law
EEO is the law - Poster Supplement
Reasonable Accommodations
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.
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