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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxters 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 Analyst II Batch Reviewer is a member of the Quality Assurance Team (QA) reporting directly to the Quality Supervisor, Batch Release. He or she performs review of all quality documentation generated during filling and/or packaging operations. He or she must communicate effectively with customer support departments to coordinate batch review and release activities to meet internal commitments and contractual commitments. He or she also provides leadership and guidance to associates with less experience and create an environment where teamwork, productivity, safety, identity, strength, purity and quality are reflected in the finished product.

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):

* Perform batch record review and final product release / disposition for GMP batches produced at Baxter for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
* Reconcile discrepancies with documentation and/or electronic systems as appropriate.
* Plan, organize, evaluate, and communicate applicable activities of designated QA batch review functions, including Quality metrics reporting.
* Resolve batch record non-conformances.
* Perform verification of Hold System activities.
* Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
* Participate in escalated client issue resolution (conference calls, responding to batch record observations)
* Subject Matter Expert for Batch Release procedures and presenting executed batch records during client and regulatory audits as required.
* Mentor and train less experienced Batch Release personnel
* Lead continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.

Job Requirements (Education, Experience and Qualifications):

* Bachelors degree in a science discipline with a minimum of 2 year Pharmaceutical Quality or Manufacturing experience, or Bachelors degree in non-science discipline with at least 5 years of Pharmaceutical Quality or Manufacturing experience.
* Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements

* Must wear appropriate personal protective equipment as applicable
* Duties may require overtime work, including nights and weekends
* Use of hands and fingers to manipulate office equipment is required
* Position requires sitting for long hours, but may involve walking or standing for periods of time.

Equal Employment Opportunity

Baxter 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.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

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 [email protected] and let us know the nature of your request along with your contact information.