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Quality Specialist

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Baxter International Inc.

10d ago

  • Job
    Full-time
    Mid Level
  • Healthcare
  • Mississauga

AI generated summary

  • You need a Bachelor’s in Science, 3+ years in quality assurance, GMP and Health Canada knowledge, product release experience, and familiarity with quality systems and IT, preferably with 3PL experience.
  • You will review lab and compliance documents, manage product dispositions, engage with partners on quality issues, oversee quality training, and contribute to process improvements.

Requirements

  • Bachelor of Science required (Sciences, Health Sciences or Pharmacy)
  • 3+ years of experience in related industry
  • Excellent knowledge of GMPs and Health Canada regulations for drug products, biologics and medical devices
  • Prior Quality Assurance experience in the Pharmaceutical or Medical Device Industry
  • Drug and/or medical device product release/product disposition experience
  • General knowledge of Quality systems (NCR/CAPA, Change Control, Documentation, Training, Product Release, Review of annual compliance documentation such as APQRs, initiate and implement Quality/Distribution Agreements in a GMP environment)
  • Working in IT systems
  • Experience working with a 3PL
  • Bachelor of Science with additional post-graduate training and certification in Quality Control/Quality Assurance preferred

Responsibilities

  • Review of laboratory documentation, transportation and warehouse receiving documentation for product releasing
  • Disposition of imported and domestic product
  • Communicates and collaborates with internal and external partners to ensure product quality, compliance, and timely testing for products distributed in Canada.
  • Communicate any issues that could impact product supply to Quality partners.
  • Handle and maintain all quality documents.
  • Manage Quality responsibilities associated with product compliance including but not limited to review and/or approval of compliance documentation such as APQR, Batch records, stability data, master manufacturing/packaging documentation.
  • Provide review and support of tasks related to launching of new products, as required.
  • Support review and approval of Quality/Distribution Agreements
  • Support 3PL oversight activities including providing post release dispositions and administration of holds, as required
  • Lead and/or participate in departmental process improvement initiatives
  • Providing Quality onboarding training sessions

FAQs

What is the main purpose of the Quality Specialist role at Baxter?

The main purpose of the Quality Specialist role at Baxter is to ensure a state of compliance and continuous improvement for all Canadian products and systems impacting the Mississauga General Office.

What qualifications are required for the Quality Specialist position?

A Bachelor of Science is required, along with 3+ years of experience in a related industry. Additional post-graduate training and certification in Quality Control/Quality Assurance is preferred.

What specific experience is needed for this role?

Candidates should have prior Quality Assurance experience in the Pharmaceutical or Medical Device Industry, as well as drug and/or medical device product release/product disposition experience.

What knowledge is essential for the Quality Specialist position?

Excellent knowledge of GMPs and Health Canada regulations for drug products, biologics, and medical devices is essential, along with a general understanding of Quality systems such as NCR/CAPA, Change Control, and Documentation.

Will I be involved in training for other employees?

Yes, the role includes providing Quality onboarding training sessions for new employees.

What are some of the key responsibilities of the Quality Specialist?

Key responsibilities include reviewing laboratory documentation, managing Quality documents, supporting new product launches, and leading departmental process improvement initiatives.

Is experience with 3PL necessary for this role?

Yes, experience working with a third-party logistics provider (3PL) is required, particularly in supporting oversight activities related to product compliance.

How does Baxter ensure a positive workplace environment?

Baxter aims to create a workplace where employees are happy, successful, and inspire each other, promoting a sense of purpose and connection to their mission of improving outcomes for millions of patients.

What should I do if I need reasonable accommodations during the application process?

If you need reasonable accommodations due to a medical condition or disability, you should click on the link provided in the job description to communicate your request and contact information.

Has Baxter experienced any recruitment fraud?

Yes, Baxter has discovered incidents of employment scams. They advise applicants to review their Recruitment Fraud Notice to learn how to protect themselves from fraudulent parties.

Baxter International Inc.

Saving and Sustaining Lives

Science & Healthcare
Industry
10,001+
Employees
1931
Founded Year

Mission & Purpose

For nearly a century, we have delivered on our commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world. We believe every person — regardless of who they are or where they are from — deserves a chance to live a healthy life, free from illness and full of possibility. At the intersection of progress and purpose is where we are redefining what it means to be a global medtech leader. It is where we are relentlessly pursuing healthcare transformation, fueled by our compassion for patients and providers and the challenges they face. It is where bold ideas meet the promise for meaningful change in the world around us. We are there, at every step of the journey, to help clinicians deliver the best care possible.

Benefits

  • Medical Coverage is available for employees and eligible family members. Employees can choose from a variety of medical plan options, balancing cost and features that best meet their needs.

  • Dental Coverage is offered separately from medical coverage, so employees may elect one without electing the other. Employees have a choice of dental plan options and coverage is also available for eligible family members.

  • Baxter provides Basic Life Insurance, Short-Term Disability, Basic Long-Term Disability and Business Travel Accident insurance at no cost to employees immediately upon hire.

  • Paid Time Off of 20 to 35 days based on length of service. Flexibility to manage your time off and use your days as you choose (vacation, personal, sick all combined into one “pool of days”).

  • Paid Parental Leave provides 12 weeks of paid time off for new mothers and fathers.