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Validation Associate II

Req # JR - 031186 Location Bloomington, Indiana Job Category Technical Services Date posted 12/18/2020

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Summary

The Technical Services Associate II (Risk Management) is responsible for risk management activities associated with non-conformances, complaints, equipment validation, qualification and change control activities at the BPS site. This position interacts with clients, regulatory agencies and cross-functional teams (Engineering, Technical Services, Manufacturing, etc.) to ensure timely approval of all associated documents. This position reports to the Technical Services Validation Sr. Manager.

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned)

  • Provide guidance and technical expertise of regulatory and Baxter requirements in Risk Management strategies and processes.
  • Assess risk associated with non-conformances complaints, audits, change control etc. and update the site process FMEA with new risks as needed.
  • Approve risk forms submitted with newly identified risk submitted via non-conformance investigations, complaints, audits, change control etc. 
  • Author and/or approve applicable risk assessment documents for equipment and manufacturing process related changes.
  • Author and/or approve applicable deviation reports for product and process related deviations.
  • Help lead Risk Management activities for sustaining Engineering/Manufacturing projects
  • Subject matter expert (SME) and key participant in compliance audits, inquiries and SOPs.
  • Provide SME input to risk remediation activities.
  • Support risk assessment of new processes to be validated.
  • Uses statistical tools to analyze data.
  • Performs annual reviews of all process FMEAs.
  • Participates in regulatory inspections.

Job Requirements (Education, Experience and Qualifications)

  • Bachelor’s degree required, preferably in a science or engineering related field
  • Minimum of 2 years pharmaceutical industry experience in parenteral manufacturing
  • American Society of Quality (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification a plus.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements

  • Must be able to wear appropriate personal protective equipment.
  • Duties may require overtime work, including nights and weekends
  • Use of hands and fingers to manipulate office equipment is required
  • Position requires sitting for long hours, but may involve walking or standing for periods of time.
  • Must be able to gown for Grade C area

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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.

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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 [email protected] and let us know the nature of your request along with your contact information.

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