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Quality Associate II, Validation

Req # JR - 019378 Location Round Lake, Illinois, United States Job Category Quality Control Date posted 04/03/2020

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Summary:

Must not be allergic to Cephalosporins or Penicillin.

This position is responsible for the development and the execution of projects which include engineering studies, validation protocols and re-validations of manufacturing facilities, equipment, utilities, computerized systems, cleaning methods, and processes. Validation activities include research, protocol writing/execution and final report generation.  Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated/implemented.  Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits.

Essential Duties and Responsibilities:

  • Perform design of experiments, develop of new methodologies and improve existing methodologies, data generation, report development and presentation.
  • Schedule, plan, communicate, and manage documents and follow-up on validation activities. Interpret and apply regulatory requirements concerning validation activities.
  • Applies knowledge of cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
  • Perform validation activities to lead cleaning, equipment, computer systems, utility, facility, and method validations.
  • Review and generate quality documents including validation protocols, SOPs, change controls, and non conformance event records as required.
  • Serves as a project lead for projects of large scope with cross-functional teams.  
  • Able to prioritize workload and tasks. Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations.

Qualifications

  • Direct experience with writing and executing validation protocols is required.
  • Understand scientific strategies and be able to invent new methods or new avenues of investigation.
  • Good interpersonal/communication/influencing/negotiation skills.
  • Strong project management skills
  • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
  • Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software helpful.
  • Direct or indirect industry knowledge.
  • Ability to work independently or in teams.
  • Physical demands of the position may require the ability to lift materials up to 20 lbs, dexterity to gown, mobility to maneuver around equipment, and enter into confined spaces without restrictions.

Education and/or Experience:

  • BS Degree in Science, Engineering or Math with at least 3 or more years of experience.

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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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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