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QA Associate - (Night Shift)

role at

Baxter International Inc.

This is where you save and sustain lives. At Baxter, we are deeply connected by our mission. Your work makes a positive impact on people around the world, and you will feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients. Baxter09s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspired to do our best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

SummaryThe Quality Assurance Associate will support the continuous compliance of the Compounding Unit to cGMP and “Specials” manufacturing requirements, local procedural requirements and Baxter Corporate policies, and assist quality operations through the release of compounded products. They will communicate significant GMP and product quality issues to QA Management, identify and support implementation of continuous improvement opportunities in QA and Operations, and investigate and report Quality issues. This role will work Sunday – Thursday, 10:00 PM to 6:00 AM.

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, 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 with actions taken to correct and trend EM data

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) and 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 qualification, maintenance and calibration activities from a quality perspective as needed

Identify and escalate supplier issues supporting their investigation per SCARs (Supplier Corrective Action Requests) or Baxter-to-Baxter (B2B) process

Education and QualificationsEligibility required:

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

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 AttributesRequired:

2 years of 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 programs including Excel

Experience with TrackWise 8 and TrackWise 9

Benefits

Competitive total compensation package

Professional development opportunities

High importance placed on work-life balance

Commitment to growing and developing an inclusive and diverse workforce

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Equal Employment OpportunityBaxter 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.

Reasonable AccommodationsBaxter is committed to providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation for any part of the application or interview process, please click the link and let us know the nature of your request with your contact information.

Recruitment Fraud NoticeBaxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees or recruiters. To learn how to protect yourself, review our Recruitment Fraud Notice.

Job Details

Seniority level: Entry level

Employment type: Full-time

Job function: Quality Assurance

Industries: Medical Equipment Manufacturing, Pharmaceutical Manufacturing, Hospitals and Health Care

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