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Quality Associate-II, QA Assurance

Baxter
Alliston, CAN
Full Time
Mid
Onsite
1 weeks ago
GMPcGMPISO standardsTrackwiseElectronic Batch Record (EBR)SPC
Free

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Overview

  • This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives.
  • Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization.
  • Support for Parents, Continuing Education/Professional Development, Employee Health & Well Being Benefits, Paid Time Off, 2 Days a Year to Volunteer.

Success Profile

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

About Baxter

  • At Baxter, we believe every person deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle.
  • Our Baxter colleagues are united by our Mission to Save and Sustain Lives.
  • We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Your Team at Baxter

  • Within Quality, every role matters. Baxter’s products are shipped worldwide to patients in need.
  • The mission of Baxter is to save and sustain lives. If there is a decision to be made where quantity and quality are at odds, we will always choose quality.
  • The Quality function values both working together as a team and independently.

What you'll be doing

  • Provide front line day to day assistance on product quality issues to ensure GMP, regulatory and procedural compliance to maintain high standards of quality.
  • Support during assigned Shift, with the requirement to support plant overtime and planned shutdowns when applicable.
  • Provide technical assistance on review and approval of department related procedural changes, product quality concerns, reinspections, new product introductions, and protocols.
  • Support timely follow up on quality exceptions and their preventative/corrective actions.
  • Support initiation/investigation and approvals of non conformance events in the Trackwise system.
  • Act as SME for Electronic Batch Record (EBR) and SPC or equivalent experience.
  • Perform change control assessments/executions and approvals.
  • Ensure control of defective WIP materials (quarantine, retention, and disposal areas) to keep segregation, movement, documentation, and timely follow up within the plant in sync with regulatory and compliance requirements.

What you'll bring Required

  • University Degree or equivalent experience, Bachelor of Science or equivalent experience.
  • 1 – 3 years’ experience in manufacturing and quality roles.
  • Prior experience working in a GMP setting.
  • Knowledge of cGMP, ISO, and regulatory standards.
  • Diligent with the ability to work effectively under pressure.
  • Strong written and verbal communication abilities, negotiation capabilities, and the capacity to collaborate with individuals at every level of the organization.
  • Ability to build positive relationships and partner with internal and external collaborators.
  • Strong ability to balance multiple priorities.
  • Strong analytical and problem solving skills with critical thinking abilities.
  • Intermediate to Advanced proficiency in MS Office Suite.

Preferred

  • 3+ years with exposure to various areas of the manufacturing environment.
  • Experience in pharmaceutical, healthcare, or food manufacturing environments.
  • Experience with continuous improvement methodologies, Lean 6S, Kaizen, TPM, DMAIC.

Compensation

  • The estimated salary range for this position is CAD 86,400 CAD 129,600 annually, which reflects base salary as well as estimated target payout under the Management Incentive Compensation Plan.
  • Individual pay will be determined based upon skills, expertise and experience.

Additional Information

  • This posting is for a current existing vacancy within our organization.
  • As part of our recruitment process, Baxter Corporation may use AI tools to assist screening candidates and assist in evaluating candidate qualifications.
  • Baxter is an equal opportunity employer.

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