Associate I, Quality Operations - NightsReq # JR - 024016 Location Alliston, Ontario, Canada Job Category Quality Control Date posted 07/15/2020
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SUMMARY OF RESPONSIBILITIES
Responsible for maintaining Quality and Compliance by ensuring product and manufacturing operations conform to Specification, Standard Operating Procedures and Regulatory Standards (Health Canada & FDA).
ESSENTIAL DUTIES AND 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 the day shift, with requirement to support plant overtime and planned shutdowns when applicable
- Provide technical support on product quality issues
- 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
- Support initiation of new non conformance events in the Trackwise system as required
- 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, 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
- 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 Nonconformace/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
- Provide support for the Quality Technical review/approval of department related procedural changes
- Other tasks, as assigned
- University Degree, Bachelor of Science - Microbiology, Chemistry, Biological Sciences, Engineering
- ASQ certification, other Quality Certification preferred
- Manufacturing & Quality background
- Previous experience in a GMP environment
- Knowledge of cGMP, ISO and Regulatory standards
- Experience: 1 – 3 years
- 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
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.