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Prep Group Leader (2nd shift)

Req # JR - 053417 Location Bloomington, Indiana, United States Job Category Assembly Jobs Date posted 11/11/2021

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

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.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

Summary

The Prep 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:

  • Understand and follow current Good Manufacturing Practices
  • Assemble and operate filtration systems
  • 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.
  • Required to maintain attendance in accordance with the Bloomington Attendance Policy
  • Scheduled weekend overtime will be required

Work Environment:  Classified pharmaceutical environment including wearing required gowning as shown in attached document.  Occasional work with water and pharmaceutical product while wearing applicable Personal Protective Equipment.  Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.

Qualification Requirements:  To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions:

  • Ability to work independently
  • Good communication skills
  • Good documentation skills, including legible handwriting
  • Good interpersonal skills
  • Basic computer skills, including ability to navigate enterprise software (ie Pilgrim, JDE, etc)
  • Basic math skills
  • Knowledge of aseptic manufacturing practices
  • Knowledge of standard operating procedures, specifications, and job-specific training materials
  • Requires the operation of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices.  Ability to demonstrate proficiency in reading equipment drawings.  Ability to work safely with equipment under pressure.

Education and Experience:  High school diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred.

Language Skills:  Must be able to understand, speak, read and write English in order to comply with necessary SOP’, job-specific training materials, GMP’s, and other manuals.

Physical Demands

  • Occasional (0-33%)
    • Sitting, climbing stairs and ladders, overhead reaching and/or lifting, balancing, kneeling, crouching, crawling, operating controls
    • Lifting and carrying up to 53 lbs
    • Pushing up to 105 lbs
    • Pulling up to 22 lbs
  • Frequent (34-66%)
    • Standing, walking, reaching forward, stooping, object handling, fingering, fine hand coordination simple and firm hand grasping
    • Lifting and carrying up to 34.25 lbs
    • Pushing and pulling up to 15 lbs

Additional Requirement:  Final candidates for Prep Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.

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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

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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