QA Assurance

Description

• 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

Qualifications

• University Degree, Bachelor of Science - Microbiology, Chemistry, Biological Sciences, Engineering / ASQ certification, other Quality Certification preferred 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
• Preferred: Experience with continuous improvement methodologies, Lean 6S, Kaizen, TPM, DMAIC