Quality Oversight Specialist

Baxter
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Baxter International

Around the world, our employees are united by our mission to save and sustain lives. Together, we create a culture that encourages colleagues to pursue rewarding careers -- where everyone has the opportunity to do meaningful work as a part of a team they respect, in an environment that values each person’s contributions. We’re happy you’re interested in continuing your career journey with Baxter.

Summary

  • Ensuring Quality Control Labs. are in compliance to Corporate Quality Manual, Health Canada, FDA,Corporate and TUV requirements.
  • Supports QC with OOL/OOS investigations, improving/initiating and supporting documentation management.
  • Supports Quality Systems Department with all additional assigned duties as required by Quality Systems manager.

General Expectations

The top two priorities for all Baxter Alliston employees are Safety and Quality:

Safety:  Support our goal to achieve a “Zero Harm Environment”, by ensuring the safety of yourself and your co-workers through:

  • Following all safety procedures
  • Wearing appropriate PPE
  • Embracing 6s

Quality: Ensure the quality of our products to ensure patient safety and achieve our mission of “Saving and Sustaining Lives”. This can be achieved through:

  • Following Good Manufacturing Practices (GMP)
  • Following Good Documentation Practices (GDP)
  • Adhering to all quality procedures
  • Completing training on-time
  • Reporting any quality concerns immediately.

As part of the plant’s Enterprise Management System (EMS), all employees must embrace a culture of Continuous Improvement by:

  • Participating in improvement activities
  • Recognizing your peers, and embracing 6s
  • Identifying and implementing VIP’s (Value Improvement Project)
  • Embrace continuous learning

Major Responsibilities / Activities

  • Daily, monitor the activities in the QC from compliance prospective including but not limited to: investigations, procedure development and improvement, documentation support.
  • Ensure that QC process is compliant to Corporate Quality Manual, Health Canada, Corporate and TUV requirements.
  • Reviews and analyzes QC data to understand and identify trends.
  • Manages all QC trending and data analysis activities and compiles information in support of Management Review Meetings.
  • Remains current with respect to regulatory trends and divisional issues.
  • Partners with facilities, divisions, and regions to ensure successful implementation and compliance to CQP/regulations.

Qualifications

Major Subjects / Specialties

Type of Experience

  • Knowledge of GMP, ISO and Regulatory standards

Preferred:

Years of Experience

Additional Skills / Special Training / Technical Skills

Required:

  • Strong process and project management capabilities.
  • Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization.
  • Strong ability to balance multiple priorities.
  • Strong analytical and problem solving skills and critical thinking abilities.
  • Intermediate to Advanced proficiency in Word, Excel, PowerPoint.

Preferred:

  • Proficiency in Trackwise System

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.                                                                                

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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

More Information

Posted

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Alliston%2C%20Canada

Alliston , Canada