QA Associate - (Night Shift)

This is where you save and sustain lives. At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary: The Quality Assurance Associate will be responsible to support in the continuous compliance of Compounding Unit to cGMP and “Specials” manufacturing requirements, local procedural requirements and Baxter Corporate policies and assisting quality operation through the release of compounded product. They will ensure timely communication of significant GMP and product quality issues to QA Management, proactively identify and support implementation of continuous improvement opportunities in QA and Operations and investigate and report on Quality issues. This role will work Sunday - Thursday between the hours of 6pm and 2pm.

Essential Duties and Responsibilities:

• Assist in the release of manufactured products according to defined procedures.
• Perform ‘in-process’ checks, report and record any errors (e.g. CPI/NCR) according to defined procedures including:
• Green Light to Release: Facility status checks
• Equipment and validated state checks
• Physical product checks
• Manufacturing and documentation checks
• Check of any outstanding Quality issues with the batch or facility.
• Supervisor checks throughout the compounding process (picking to release)
• Escalate and resolve any observed product quality issues in a timely manner, ensuring GMP is adhered to at all times.
• Ensure product complaints and service complaints are adequately investigated and appropriate corrective and/or preventative actions are implemented.
• Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct and EM trend analysis.
• Ensure facility and process compliance through Real Time Risk Assessments and GEMBA walks, identifying actions and facilitating implementation.
• Proactively identify and support implementation of continuous improvement opportunities in QA and Operations.
• Comply with EHS/GMP/GDP/Company and Corporate policies and external regulatory requirements.
• Review and approve planned and unplanned controlled system work orders (CSW) & Maximo.
• Raise and Investigate non-conformance reports (NCRs), define, execute and track appropriate CA/PA actions.
• Support reviews of production processes (to meet regulatory and customer requirements) from a quality perspective.
• Support the qualification, maintenance and calibration activities from quality perspective as needed.
• Identify and escalate supplier issues supporting their investigation as per SCARs (Supplier Corrective Action Requests) or B2B (Baxter to Baxter complaints) process.

Education and Qualifications:

Eligibility required: Resident and eligible to work in the UK or Ireland on a full-time basis.

Education: English minimum equivalent to RQF Grade 2, EQF Grade 3 or SCQF Grade 5 Degree or BTEC (or equivalent) in Pharmaceutical or Science related subject.

Experience and Attributes:

Required: 2 Years experience in a GMP Environment.

Field of expertise preferred: Quality Assurance, Production, Validation, Microbiology. Aseptic Manufacture of medicinal products is preferred but not required.

Preferred: Strong working knowledge of Microsoft Office programmes including Excel. Experience of TrackWise8 and TrackWise9.

What are some of the benefits of working at Baxter?

High importance placed on work life balance. Commitment to growing and developing an inclusive and diverse workforce.