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Product Surveillance Quality Assoc II

Req # JR - 023552 Location Bloomington, Indiana, United States Job Category Quality Control Date posted 06/26/2020

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Summary

The Product Surveillance Quality Associate II will process, investigate, author, and manage complaints reported by the client alleging deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, and performance of a product after it is released by Baxter to the client.  Regulatory compliance requires the prompt evaluation of reported complaints to confirm the validity of the complaint and the potential for strength, identity, safety, purity and quality (SISPQ) impact to product distributed to the field.  Associates will interact with clients to obtain necessary information required to investigate the reported complaint and provide documentation/updates on complaint investigations.  Using root cause analysis techniques, associates will evaluate complaints for assignable or determinate root cause and will work with subject matter experts to eliminate/mitigate risk through initiation of corrective and preventive actions.  Associates will also support monitoring of complaint management performance, including trending and data analysis.  This position reports to the Manager, Quality Compliance.

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

  • Investigate, author, and manage multiple high-risk, complex complaint simultaneously
  • Document and process complaint information in the complaint workflow of the TrackWise system
  • Communicate with clients to obtain necessary information, including the initial facts of the complaints, clarification of event descriptions, sample analysis, client-provided retain sample inspection data, ongoing follow-up, etc.
  • Determine problem codes, initiate complaints, and provide information to clients for each complaint
  • Review executed batch records, Standard Operating Procedures, Non-conformances in support of complaint investigations
  • Evaluate information from the complaint sample to determine and define an investigation plan
  • Visually/functionally evaluate return samples and work with subject matter experts or laboratory personnel for evaluation/analysis, as applicable
  • Observe production activities and interview operators to narrow the investigation
  • Utilize root cause analysis tools to identify assignable or determinate root cause and associated corrective action and preventative action (CAPA)
  • Synthesize logical conclusions from available data streams to present clearly-written, detailed reports for consumption by third parties (clients, inspectors, regulatory agencies)
  • Manage approval panel workflow and provide the closed complaint to the client
  • Assist in filing/follow-up of Supplier Corrective Action Reports
  • Assist in peer review of complaint files
  • Assist in department trend reporting; performance of primary analysis and preparation of presentations
  • May participate in the generation, review, or approval of other quality system-impacting documents as needed
  • Supports client, regulatory, or other audits as needed.

Qualifications

  • Bachelor’s degree required, preferably in chemistry, biology (or related science field), engineering
  • Minimum 3 years’ experience in Quality Assurance, Quality Control, or pharmaceutical manufacturing (knowledge of cGMPs and their applications)
  • Computer proficiency in Microsoft Word, Excel, and Outlook and preferably the ability to use enterprise software (examples include:  JDE, TCU, TrackWise, Minitab, etc.)

Physical / Safety Requirements

  • Must be able to gown qualify for Grade C/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.

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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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