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—where your purpose accelerates our mission.

Your role at Baxter

This position is responsible for ensuring that CIVA is compliant with NAPRA, cGMP, applicable license(s) and the Baxter Quality Management System. As the Sterile Compounding Supervisor, this position develops, organizes and oversees all activities related to sterile-preparation compounding. This role will be primarily focused on Quality Operations, while supporting Quality Systems.

What you will be doing

Collaborate with Operations to assess quality risk and address compliance gaps.Lead resolution of daily operational quality issues and provide product disposition in a timely manner.Apply expertise in critical production areas to ensure timely and efficient product release.Maintain audit-ready state and host/participate in internal and external audits.Provide Quality support to CIVA projectsPerform other Quality duties as assigned

Sterile Compounding Supervisor

Perform all functions of Sterile Compounding Supervisor per NAPRA Model Standards for Pharmacy Compounding of Hazardous/Non-Hazardous Sterile PreparationsMain point of contact for all communications with OCPLead execution of and response to annual OCP inspectionAssess proposed changes for compliance to NAPRA requirementsReview and approve semi-annual cleanroom/PEC certifications, daily/weekly/monthly cleaning logs, semi-annual process simulations, monthly EM trend report

Complaints

Log and track external and B2B complaintsLiase with Product Surveillance to effectively process complaintsManage the return of complaint samplesComplete evaluation of complaint samples, perform manufacturing record review and investigations, as necessaryUpdate metrics

NCR/CAPA

Provide support for the initiation, timely completion and closure of Operations NCR/CAPAs in Trackwise 8 by owning or approving records as neededCollaborate with Operations to identify and implement corrective and preventive actions and evaluate effectivenessProvide appropriate product disposition for impacted productSupport implementation of new business/new admixtures and product/process changes at CIVAComplete Quality assessments and identify required tasks to implement changesComplete assigned change control tasks in a timely fashion

What you will bring

B.Sc. (Pharmacy or Microbiology)Pharmacist or Pharmacy Technicial registered with Ontario College of PharmacistsStrong problem-solving, critical thinking and analytical skillsAbility to prioritize multiple tasksSelf-driven to initiate and implement continuous quality improvementExcellent written/oral communication and organizational skillsAbility to work autonomouslyTrained in compounding of sterile preparationsTechnical expertise in aseptic processing/techniqueExperience in supervising sterile compounding activitiesRelevant QAGMP knowledge and experienceKnowledge of parenteral products and their intended useLean or Six Sigma

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.