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Quality Associate III

Req # JR - 026961 Location Bloomington, Indiana, United States Job Category Quality Control Date posted 09/03/2020

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Summary

The Quality Supervisor – Product Surveillance provides direct supervision to Quality Product Surveillance staff. Plans and schedules the work of Quality Product Surveillance Associates. This position reports to the Manager II, Quality.

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

  • Monitors implementation and compliance of the requirements established by the Plant’s Quality System. Plans, schedules, coordinates, supports, and leads detailed complaints of facility practices to ensure that policies and procedures comply with worldwide regulatory agencies and Corporate Quality Policy guidelines. This includes review of updated Good Manufacturing Practices (GMP) regulations and current FDA and outside of US requirements and incorporation into internal programs, where appropriate.
  • Assists in planning and developing complaint assessment and logistics.  Reports on facility’s weaknesses, ineffective procedures, policy exceptions and discrepancies and recommends appropriate corrective actions. Evaluates corrective and preventive action responses to complaint findings for adequacy, including root cause and timeliness.
  • Conducts and confirms follow-up actions on complaint corrective and preventative actions.  Supports routine GMP and Pre-Approval Inspection regulatory audits.  Interfaces with regulatory inspectors during audits.
  • Supports the development and monitoring of appropriate metrics for facility complaint performance.  Reports trends to management when required for internal metrics. 
  • Provides Quality Product Surveillance information for Annual Product Reviews.
  •  Leads lean initiatives and projects for improvements to the complaint quality systems and initiates recommended improvements.
  • Supports hiring, training, and evaluation of all complaint personnel. 

Job Requirements (Education and Experience)

  • Bachelor's degree required, preferably in a scientific or technical discipline
  • Minimum 5  years experience in the pharmaceutical/biotech industry.
  • Previous product complaint experience preferred.
  • Thorough knowledge of worldwide regulatory agency regulations.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements

  • Must be able to gown qualify for Grade C and D production areas
  • Duties may require overtime work, including nights and weekends
  • Use of hands and fingers to manipulate office equipment is required
  • Position may require sitting or standing for long hours. 
  • Must be able to work with post-use product and potential blood borne pathogens.

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. 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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