Prep Group Leader (3rd Shift)
Location: Bloomington, Indiana
Posted: May 12, 2017
Reference ID: 17000401
Assemble and operate filtration systems
Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You'll find Baxter's products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter's employees are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.
The Preparation Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor. They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Preparation Operators who perform in the manufacturing areas. The Preparation Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Baxter Standard Operating Procedures. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments. The Preparation Group Leader creates and environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):
Operate general production equipment (such as autoclaves, vial washers, depyrogenation ovens, scales and balances, etc)
Monitor and record critical process parameters
Complete all relevant paperwork following GDP/GMP guidelines
Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
Perform sampling using aseptic techniques
Participate on Continuous Improvement Teams
Train and mentor other team members
Write, revise and review pertinent documentation as appropriate
Troubleshoot process problems and respond to process alarms
Assist with process/equipment validation and data analysis
Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion.
Job Requirements (Education, Experience and Qualifications):
High School Diploma or GED required
6 months previous Pharmaceutical Manufacturing experience preferred
2 years of experience operating and troubleshooting complex production equipment preferred
Knowledge of cGMP and GDP practices preferred.
Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems preferred.
Proficiency in a variety of mathematical disciplines and ability to work with both the metric and USA standards of measurement required.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
There are minimum training requirements for each operator level
Physical / Safety Requirements:
Ability to stand 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)
Duties may require overtime work, including nights and weekends
Use of hands and fingers to manipulate office equipment is required
Must be able to gown qualify for Grade A/B areas.
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 email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.