Job Description

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\xe2\x80\x94where your purpose accelerates our mission.

Summary

To provide an effective and compliant release service for Baxter Elstree. This will be achieved through QC checking, batch and document review, and support for investigations into non-conformances, CAPAs and complaints. Working with the Quality Assurance Manager, Production Manager and Production Team Leader to provide Operational QA service to Baxter Elstree. This will be achieved through:

Essential Duties and Responsibilities

Sampling of intermediate products within the manufacturing process.

Testing and inspection of product, as required by SOP and Finished Product Specification.

Co-Ordination of product testing with external contract laboratories.

Maintain compliance with ISO 13485 and FDA (21 CFR) part 820 and the requirements of MDSAP.

Product Release:

Compilation of release data for finished products.

Co-ordination of product bioburden data.

Co-ordination of product endotoxin testing.

Collation and completion of documentation to support release.

Inspection of sterilized finished product received back from subcontractors.

Support to releasers for disposition/release of finished product.

Co-ordination of samples for laboratory testing

Goods Inwards Quality Control:

Inspection of goods and material dispositioning.

Co-ordination of samples for laboratory testing

Co-ordination of investigations into non-conforming product.

Calibration/Maintenance Control:

Support of calibration, maintenance and revalidation activities for equipment and facilities.

Monitoring of schedule and tracking execution of activities.

Documentation Control:

Maintenance of document control system \xe2\x80\x93 paper and electronic.

Co-ordination of documentation control activities, liaising with appropriate personnel to progress updates, approvals, with responsibility for publishing approved documents.

Control of Batch Documentation:

Responsibility for filing/archiving completed DHRs and batch/order documentation post release, to enable rapid retrieval.

Quality Assurance/Control:

Adherence to Baxter Elstree\xe2\x80\x99s relevant policies and procedures at all times, and notification of any deviations/exceptions from process.

Support for all aspects of the QMS through participation in internal audit as trained and approved auditors and support for incidences such as complaints, and any subsequent field corrective actions/recalls.

Support for and co-ordination of Quality Investigations i.e. NCR/CAPA/Complaint handling, and logging/issuing of QMS numbers.

Qualifications

Additional training in Quality Assurance, Quality tools, statistics, qualification/ validation, Six Sigma / Continuous Improvement tools and medical device/pharmaceutical regulation.

Experience of working to ISO13485 and FDA (21 CFR) part 820 compliant systems. QA experience in a Clean room environment \xe2\x80\x93 sterile / aseptic manufacturing. Internal Auditing experience. Familiarity with NCR/CAPA, complaint and document control processes within a regulated Quality Management System.

Working in a fast paced, rapidly changing environment, supporting new product introduction.

Excellent investigational, analytical and problem solving skills. Ability to review and monitor data, and identify trends.

Highly proficient communicator, both verbal and written.

QA, cGMP and Quality Systems in an Operational Quality environment. Knowledge of clean room control requirements.

What are some of the benefits of working at Baxter?

Competitive salary + benefits

Professional development opportunities

High importance placed on work life balance

Commitment to growing and developing an inclusive and diverse workforce

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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