Pharmaceutical QA Complaint Specialist III

  • Location
    Austin, Texas
  • Job type
  • Salary

Under general direction, the Quality Specialist II will perform a variety of complex duties associated with managing product complaints and supporting patients/customers associated with pharmaceutical, biologics, and combination products. The Quality Specialist will initiate, own, processes, maintain, and conclude complaint files including determination of the appropriate investigation team based on manufacturing/packaging site and complaint type and nature. The Quality Specialist II will determine the appropriate root cause, conclusion, and action plan based on the investigative findings.

Key Duties and Responsibilities:
-Initiate, evaluate, assess and maintain complaint files, following complaint handling internal procedures.
-Initiate and set up child records. Maintain and update Global TrackWise database. Record all complaint activity in both hard copy (when applicable) and TrackWise records.
-Assess incoming documentation from intake group and ascertain compliance to product specification and/or intended use as indicated in the product labeling.
-Expedite shipments for Complaint Sample Retrieval.
-Solicit investigation status updates directly from site of manufacture/packager and evaluate analysis results on all submitted records.
-Collaborate with manufacturing sites, packaging sites, third party quality, and corporate quality to make and document appropriate regulatory decisions.
-Advise site to initiate further complaint investigations, and provide any additional follow-up and communication pertinent to the product complaint as needed.
-Evaluate Complaint Investigation results, and close records when all requirements are met.
-Maintain a knowledge and understanding of current product labeling, other federal laws governing pharmaceutical complaints, Department of Transportation (DOT) requirements for complaint sample returns, and other global regulatory requirements as needed.
-Handle sensitive conversations with patients and/or physicians, avoiding litigious or compromising issues
-Initiate and process product reimbursement.
-Respond to verbal and written requests from internal and external customers for compensation of product quality complaints and adverse events.

-Bachelor's degree, with three to five years of previous experience in Pharmaceutical Quality, Regulatory, Clinical, and/or Customer Management (in a regulated environment) setting; or equivalent combination of education and experience.
-Ability to problem solve through vague and unclear information.
-Ability to read, analyze, and interpret common scientific and technical journals, financial reports, medical reports, and legal documents.
-Ability to respond to common inquires or complaints from customers, regulatory agencies, or members of the business community.
-Ability to handle confidential data in accordance with HIPAA and related international standards.
-Knowledge of clinical, surgical techniques and procedures, and medical terminology.


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Reference number US_EN_1_027673_11785094