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 Associate I Line Operations is a member of the Quality Assurance Line Operations Team reporting directly to the Quality Supervisor. They maintain quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during manufacturing processes. They also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter Standard Operating Procedures. This position strives for continuous improvement of processes and contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) 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)

* Ensures compliance with all worldwide regulatory agency requirements and company-specific regulations related to quality of product and employee safety.
* In-process review of records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements. Records include batch records and other documents involved in the aseptic processing of drug product.
* Reports errors, deficiencies, discrepancies and observations to management. May stop operations when product safety is or may be compromised.
* Performs Quality functions in classified areas, including production oversight, manufacturing process assessments, aseptic intervention oversight, and line clearances.
* Reviews completed terminal sterilizer, lyophilizer, depyrogenation, and autoclave charts.
* Provides review of completed work orders and proposed standard operating procedure revisions.
* Works in collaboration with management teams to prepare for internal and external audits. Assists with timely closure of audit observations and CAPAs.
* Initiates and authors Nonconformance Reports and corrective and preventative action responses.
* Conducts bi-annual inspections of classified areas in preparation for facility shutdown periods.
* Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement.
* Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation.

Job Requirements (Education, Experience and Qualifications)

* Bachelors degree in a science discipline, or Bachelors degree in non-science discipline with at least three 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 PPE as required for various manufacturing areas
* Must be able to gown qualify for Grade A/B areas.
* Duties will require overtime work, including scheduled weekend shifts
* 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.

IND-USOPS

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.