Quality Associate-II, QA Assurance - Day shift (Monday to Friday 8:00-16:30)

Responsibilities

• 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.
• Willingness to learn and adapt quickly.
• Join Baxter Healthcare Corporation and become part of a group that is impacting healthcare every day!
• Garbing Processes
• This posting is for a current existing vacancy within our organization. We are actively seeking qualified candidates to fill this open position. If you are interviewed for this position, we will advise you within 45 days of the interview
• as to whether or not you wer

Benefits

Additional Information

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your Role at Baxter This is where your creativity addresses challenges You are creative, detailed, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality Associate-II, QA Assurance, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality. Your Team at Baxter Within Quality, every role has an impact. Baxter ships products worldwide to patients in need. Whether building a new process or solving a unique production challenge, Quality team members have the trust and chance to be creative. No matter your role, your work will affect part of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always. The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to build top-of-the-line products. We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps develop a better product for our customers.

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