Full-Time

Quality Specialist II

Operations

Confirmed live in the last 24 hours

Baxter International

Baxter International

10,001+ employees

Provides essential medical products and services

No salary listed

Mid

Mississauga, ON, Canada

In Person

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Requirements
  • B.Sc. (Pharmacy or Microbiology)
  • Pharmacist or Pharmacy Technician registered with Ontario College of Pharmacists
  • Strong problem-solving, critical thinking and analytical skills
  • Ability to prioritize multiple tasks
  • Self-driven to initiate and implement continuous quality improvement
  • Excellent written/oral communication and organizational skills
  • Ability to work autonomously
  • Trained in compounding of sterile preparations
  • Technical expertise in aseptic processing/technique
  • Experience in supervising sterile compounding activities
  • Relevant QA
  • GMP knowledge and experience
  • Knowledge of parenteral products and their intended use
  • Lean or Six Sigma
Responsibilities
  • 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 projects.
  • Perform other Quality duties as assigned.
  • Perform all functions of Sterile Compounding Supervisor per NAPRA Model Standards for Pharmacy Compounding of Hazardous/Non-Hazardous Sterile Preparations.
  • Main point of contact for all communications with OCP.
  • Lead execution of and response to annual OCP inspection.
  • Assess proposed changes for compliance to NAPRA requirements.
  • Review and approve semi-annual cleanroom/PEC certifications, daily/weekly/monthly cleaning logs, semi-annual process simulations, monthly EM trend report.
  • Log and track external and B2B complaints.
  • Liase with Product Surveillance to effectively process complaints.
  • Manage the return of complaint samples.
  • Complete evaluation of complaint samples, perform manufacturing record review and investigations, as necessary.
  • Update metrics.
  • Provide support for the initiation, timely completion and closure of Operations NCR/CAPAs in Trackwise 8 by owning or approving records as needed.
  • Collaborate with Operations to identify and implement corrective and preventive actions and evaluate effectiveness.
  • Provide appropriate product disposition for impacted product.
  • Support implementation of new business/new admixtures and product/process changes at CIVA.
  • Complete Quality assessments and identify required tasks to implement changes.
  • Complete assigned change control tasks in a timely fashion.
Desired Qualifications
  • Lean or Six Sigma

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in hospitals, clinics, and home healthcare, catering to patients in various settings from emergency rooms to intensive care units. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Company Size

10,001+

Company Stage

IPO

Headquarters

Deerfield, Illinois

Founded

1931

Simplify Jobs

Simplify's Take

What believers are saying

  • Needle-free injection technology could enhance accessibility of Baxter's pharmaceutical products.
  • Investment in Medically Home aligns with the trend towards decentralized healthcare.
  • Partnership with Ayogo Health could improve patient adherence and outcomes in home dialysis.

What critics are saying

  • Needle-free technology may disrupt traditional injection-based therapies, affecting Baxter's market share.
  • Home-based healthcare solutions may require adaptation of Baxter's hospital-focused model.
  • Shift towards digital health solutions may necessitate significant investment in technology.

What makes Baxter International unique

  • Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.
  • Partnership with Ayogo Health integrates behavioral science into renal care solutions.
  • Strategic investment in Medically Home positions Baxter in the hospital-at-home market.

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Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Company News

TechCrunch
Mar 31st, 2022
Novaxs Biotech Raises $1.5M To Make Injection Therapy Needle-Free

A startup spawned from a lab at the University of California, Berkeley has won investor support to work on its patented needle-free injector, which it hopes can make therapies that traditionally require daily self-administered medicines less painful. NovaXS Biotech, founded by 21-year-old Berkeley researcher Alina Su in 2020, recently closed a $1.5 million seed round []

PR Newswire
Jan 10th, 2022
Medically Home Announces a $110 Million Strategic Investment Led by Baxter International Inc., Global Medical Response and Cardinal Health to Advance Leadership in Hospital-Level Patient Care at Home

/PRNewswire/ -- Medically Home today announced a new, $110 million round of funding from strategic investors including Baxter International Inc., Global...

FreightWaves
Sep 12th, 2020
Canfor, 4 others named FourKites Golden Kite Award winners

Five companies have been named FourKites Golden Kite Award winners for their successful integration of, and results from, using FourKites technology to improve customer service and operations.

s29755.pcdn.co
Sep 12th, 2020
Canfor, 4 others named FourKites Golden Kite Award winners

Five companies have been named FourKites Golden Kite Award winners for their successful integration of, and results from, using FourKites technology to improve customer service and operations.

CanHealth
Aug 5th, 2020
Baxter and Ayogo partner on home dialysis

DEERFIELD, Ill. and VANCOUVER, BC – Baxter International Inc., a global innovator in renal care, and Ayogo Health Inc., a behavioral science-based digital health company, announced the expansion of their partnership to support the needs of patients with kidney disease through digital health solutions. Ayogo is