Quality Operations Associate I – Night Shift

Job title: Quality Operations Associate I – Night Shift

Job description: This is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining lives-where your purpose accelerates our mission.As a Quality Associate – I you will be responsible for maintaining Quality and Compliance by ensuring product and manufacturing operations confirm to Specification, Standard Operating Procedures and Regulatory Standards (Health Canada & FDA). This role for Quality Associate – I position is for night shift schedule.Responsibilities: Provide front line day to day support on product quality issues to ensure GMP, regulatory and procedural compliance to maintain high standards of qualitySupport the day shift, with requirement to support plant overtime and planned shutdowns when applicableProvide technical support on product quality issuesPartner with Quality and Production personnel to ensure mitigating actions are identified and implementedSupport timely follow-up on quality exceptions and their preventative/corrective actionsSupport initiation of new non conformance events in the Trackwise system as requiredSupport release process by performing final release of products to distribution by ensuring product conforms to specifications, SOPs and regulatory requirementsSupport 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 requirementsEnsure shop floor presence by performing process walkabouts and supporting operations to remediate issues that are identifiedUse trending reports of quality exceptions to partner with Production personnel to determine opportunities to improve processes and reduce exceptionsSupport complaint and CAPA investigations, when requiredConduct robust DMAIC Nonconformace/CAPA investigations, when requiredConduct 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 PolicyAttend the weekly/daily Tier meetings to present quality and compliance issuesLeads and participates in continuous improvement projects with the objective of achieving quality, reliability and cost improvement goalsSupports audits with regulatory authorities on quality and compliance issuesSupports an Audit ready state by performing GEMBAs and following up with area owners to ensure timely closure of observationsProvide support for the Quality Technical review/approval of department related procedural changesEducation and Experience:University Degree, Bachelor of Science – Microbiology, Chemistry, Biological Sciences, Engineering1- 3+ years experienceASQ certification, other Quality Certification preferredManufacturing & Quality backgroundPrevious experience in a GMP environment with Knowledge of cGMP, ISO and Regulatory standardsDetail oriented with the ability to work under pressureStrong 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 analytical and problem-solving skills with critical thinking abilities.Intermediate to Advanced proficiency in MS Office Suites#IND-CA#LI-RW1Reasonable AccommodationsBaxter 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. 038660

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Location: King City, ON

Job date: Wed, 02 Jun 2021 01:17:15 GMT