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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Job Responsibility
Monitor the complaint system for new complaints daily
Review and assess all complaints
Conduct investigations to determine the cause(s) of complaints as per site procedures
Own the site Complaint procedures and conduct necessary changes to ensure compliance
Provide periodic updates about Complaints to collaborators, including Quality and Operations
Perform sample analysis for returned samples and document results
Review and analyze cumulative complaint data to identify significant issues
Lead the Complaint Technician in achieving goals and developing skills
Requirements
Knowledge and experience applying current GMPs, ISO, and regulatory standards (Health Canada, FDA)
Experience in a Pharmaceutical Manufacturing environment
Strong analytical, problem-solving, and critical thinking abilities
Risk Management knowledge (e.g., ICH Q9: Quality Risk Management)
Ability to balance multiple priorities and attention to detail
Leadership skills and ability to work with multi-functional teams
Intermediate to Advanced proficiency in Word, Excel, PowerPoint