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:

TheQuality Control ChemistrySupervisor directsand evaluatesthedailyactivities of the qualitychemistrylaboratory.The position is responsible for qualitychemistrylaboratory staff oversight, technical performance,troubleshooting, and leading investigations. The Supervisor alsoleadsarea audits, createsand maintainsquality documents andensuresregulatory compliance. This position reports to the ManagerI,Quality.

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

* Reviews laboratory documentation for accuracy and completeness

* Creates, reviews, and revisesstandard operating procedures (SOPs).

* Writes reports, protocols,Capital Purchase Agreements (CPAs)and other appropriate documentation for proper functioning of the department

* Performs personnel management activities, including interviewing, hiring,training,employee performance review, performance management, and recommending promotions.

* Conducts laboratory investigationsandwritesLaboratory Investigation Reports andNonconformanceReports

* Leads laboratory audits for clients as well as regulatory agencies

* Trains employees on test methods and instrument use

* Trouble-shoots laboratory testing problems

* Oversees testing including HPLC, biological assays, analytical instrumentation, andPharmacopialwet chemistry techniques

* Leadscontinuous improvementteams which increase efficiency, solve problems, generate cost savings and improve quality

* Serves as a mentor to other QualityLabAssociates

* Provides training and work direction for all QualityLabAssociate positions

* Performs internal laboratory checklist and audits as required

* Reviews and approves Exception Reports, Master Batch Records, research and development protocols, summary reports, Master Change Controls, Laboratory Investigation Reports

* Reviews and signQuality Control Master Documents (QCMDs), stability tables, raw materialCertificates of Analysis (CofAs), andBaxterAnalyticalRequests (BAR)forms as required

Job Requirements (Education,Experienceand Qualifications):

* Bachelors degree in a physical science related field with a minimum 5years pharmaceutical laboratory experience

* Minimum 1 year leadership experiencepreferred

* Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

* Knowledge and navigation skills of QC documentationrequired

Physical / Safety Requirements:

* Must be able to wear personal protective equipment.

* Duties may require overtime work, including nights and weekends

* Use of hands and fingers to manipulate office equipment is required

* Position may require sitting or standing for long periods of time.

* This position requires handling of laboratory chemicals

* Must be able to qualify for 20/40 corrected vision.

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.