Quality Associate-I, QA Assurance-Midnight shift (Sunday to Thursday 23:00h-7:30h)

Baxter International Inc.•Alliston, ON

8d•Onsite

About The Position

At Baxter, every person deserves a chance to live a healthy life. Founded in 1931, Baxter is redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Baxter colleagues are united by the Mission to Save and Sustain Lives, driven by a culture of courage, trust, and collaboration. Individuals are empowered to take ownership and make a meaningful impact, striving for efficient and effective operations and holding each other accountable for delivering exceptional results. This role offers purpose and pride. As a Quality Associate-I, QA Assurance, you will be responsible for maintaining Quality and Compliance by ensuring product and manufacturing operations conform to Specifications, Standard Operating Procedures and Regulatory Standards (Health Canada & FDA). The shift time for this position is Midnight shift (Sunday to Thursday 23:00h-7:30h EST).

Requirements

University Degree, Bachelor of Science - Microbiology, Chemistry, Biological Sciences, Engineering / ASQ certification, other Quality Certification or Combined Equivalent in Work Experience
Minimum 3 Years of experience required
Manufacturing and quality background
Previous experience in a GMP environment
Knowledge of cGMP, ISO, and Regulatory standards
Detail oriented with the ability to work under pressure
Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization
Ability to build strong relationships and partner with internal and external stakeholders
Strong ability to balance multiple priorities
Strong analytical and problem-solving skills with critical thinking abilities
Intermediate to Advanced proficiency in MS Office Suite

Nice To Haves

Experience with continuous improvement methodologies, Lean 6S, Kaizen, TPM, DMAIC

Responsibilities

Provide front line day to day support on product quality issues to ensure GMP, regulatory and procedural compliance to maintain high standards of quality
Support on assigned shift, with requirement to support plant overtime and planned shutdowns when applicable. Support to other shifts will be required to add coverage as necessary
Provide technical support on review/approval of department related procedural changes product quality issues, reinspection, new product introduction and Protocols
Partner with Quality and Production personnel to ensure mitigating actions are identified and implemented
Support timely follow-up on quality exceptions and their preventative/corrective actions (Exception, Deviations, Document Approvals, etc.)
Support initiation/investigation and approvals of non-conformance events in the Trackwise system
Support release process by performing final release of products to distribution by ensuring product conforms to specifications, SOPs and regulatory requirements
Support Quality IT Systems (SPC Infinity, EBR, BMTCS, etc.)
Ensure control of defective WIP materials (quarantine, retention and disposal areas) to ensure adequate segregation, movement, documentation and timely follow-up within the plant to comply with Regulatory and Compliance requirements
Ensure shop floor presence by performing process walkabouts and supporting operations to remediate issues that are identified
Maintain Quality operations KPIs and Management review data
Use trending reports of quality exceptions to partner with Production personnel to determine opportunities to improve processes and reduce exceptions
Support complaint and CAPA investigations, when required
Conduct robust DMAIC Non-conformance/CAPA investigations, when required
Conduct documentation reviews in the plant for compliance with existing procedures and instructions, and verify the effectiveness of procedures and instructions versus Baxter Corporate requirements and Regulatory Requirements
Maintain Alliston files in accordance with the Quality Retention Policy
Attend the weekly/daily Tier meetings to present quality and compliance issues
Leads and participates in continuous improvement projects with the objective of achieving quality, reliability and cost improvement goals
Supports audits with regulatory authorities on quality and compliance issues
Supports an Audit ready state by performing GEMBAs and following up with area owners to ensure timely closure of observations
Other tasks, as assigned