Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
Summary of Responsibilities
- As part of the Quality Operations team, ensure Quality compliance for the assigned departments.
- Support a manufacturing 3-shift operation, with requirement to support plant shutdown where applicable.
- Partner with Quality and Production personnel to ensure robust complaint and CAPA investigations are performed and mitigating actions are identified and implemented.
- Lead robust product complaint investigations and DMAIC Nonconformance/CAPA investigations in compliance with Corporate Quality Policies, Health Canada, and TUV requirements.
- Utilize the Trackwise system for documentation of complaint evaluation tasks and CAPA investigation results.
- Support initiation of new nonconformance events for in the Trackwise system, as required.
- Provide front line day to day management, coaching and technical support on product quality issues to ensure GMP, regulatory and procedural compliance and maintain high standards of quality to ensure root cause and preventative measures are identified and corrective and preventative actions are taken.
- Provide support for the Quality technical review/approval of department related procedural changes.
- Ensure that validation protocols are written, executed, and documented in accordance with Corporate Quality Policies, Health Canada, and ISO requirements.
- Partner with the Quality Engineer team to ensure synergies in investigations and corrective/preventative actions.
- Partner with the Quality Engineer team to support the development, training, and coaching for the Alliston Lean Boot Camp and Greenbelt programs.
- Support the Quality IT Systems for the department (i.e. SPC Infinity).
Safety:Support our goal to achieve a “Zero Harm Environment”, by ensuring the safety of yourself and your co-workers through:
- following all safety procedures
- understanding potential hazards in your area
- wearing appropriate PPE
- reporting all incidents / near-misses / concerns
- embracing 6s
Quality: Ensure the quality of our products to ensure patient safety and achieve our mission of “Saving and Sustaining Lives”. This can be achieved through:
- following Good Manufacturing Practices (GMP)
- adhering to all quality procedures
- completing training on-time
- Doing it Right the First Time, and
- reporting any quality concerns immediately.
As part of the plant’s Enterprise Management System (EMS), all employees must embrace a culture of Continuous Improvement by:
- participating in improvement activities
- identifying and implementing continuous improvement ideas
- participating in Tier meetings
- recognizing your peers, and
- embracing 6s.
- identifying and implementing VIP’s (Value Improvement Project)
- embrace continuous learning
- utilize Leader Standard Work
- utilize Root Cause Analysis tools to identify and prevent problems from recurring and drive measurable results.
Essential Duties and Responsibilities
- Supports initiation of new nonconformance events for the Viaflex Mixing/Filling department in the Trackwise system.
- Leads robust DMAIC Nonconformance/CAPA and complaint investigations in compliance with Corporate Quality Policies, Health Canada, and TUV requirements.
- Partners with Quality and Production personnel to ensure mitigating actions are identified and implemented.
- Utilizes the Trackwise system for documentation of nonconformance/CAPA investigation results.
- Partners with the Quality Engineer team to ensure synergies in investigations and corrective/preventative actions.
- Design IQ/OQ/PQ and validation campaigns as well as develop, prepare and write the protocols for process validation, cleaning validation, IQ/OQ and performance qualification
- Coordinate validation and IQ/OQ/PQ activities with Production, Quality Control Laboratories and outside contractors providing leadership, training and guidance.
- Monitor and support the execution of the protocols through training, facilitating and problem solving activities
- Create validation packages for systems, processes, cleaning procedures, analytical methods and equipment to demonstrate a validated state of control. Write protocols, manage the execution of validation testing plans by liaising with other departments to coordinate validation activities, compile and analyze data, perform statistical analysis and prepare validation packages.
- Perform retrospective validation packages as required for legacy systems and processes.
- Prepare or assist in the preparation of Validation Maintenance packages.
- Provides front line day to day management, coaching and technical support on product quality issues to ensure GMP, regulatory and procedural compliance and maintain high standards of quality to ensure root cause and preventative measures are identified and corrective and preventative actions are taken.
- Provides support for the Quality technical review/approval of department related procedural changes, and validations/protocols.
- Remains current with respect to regulatory trends and divisional issues.
- Partners with facilities, divisions, and regions to ensure knowledge sharing and successful implementation of Quality improvement initiatives.
- Partners with the Quality Engineer team to support the development, training, and coaching for the Alliston Lean Boot Camp and Greenbelt programs.
- Support the Quality IT Systems for the department (i.e. SPC Infinity).
- Completes requested month end summary/metric reports for Management Review meeting.
- Support the Baxter Quality System Improvement Plan (QSIP) by ensuring that quarterly Quality Quotient assessments are completed and opportunities are identified and action plans created.
- Bachelor of Science, required.
- ASQ Certified Quality Engineer, preferred.
Major Subjects / Specialties
- Science (Chemistry, Microbiology, Pharmacy, Engineering), required.
Type of Experience
- Manufacturing & Quality background
- Previous experience in a GMP environment
- Knowledge of GMP, ISO and Regulatory standards
- Knowledge of Corporate Quality requirements
Years of Experience
- 2 – 3 years experience in a pharmaceutical environment, required.
- 5+ years of successful experience in a pharmaceutical environment, preferred.
Additional Skills / Special Training / Technical Skills
- Certified Greenbelt designation.
- Strong understanding of Health Canada GMP and Medical Device Regulations.
- Thorough knowledge of applicable procedures, specifications, regulations and standards.
- Strong process and project management capabilities.
- Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization.
- Ability to build strong relationships with internal and external customers.
- Strong ability to balance multiple priorities.
- Role model personal accountability for results and integrity and relentless focus on rapid and disciplined action.
- Strong analytical and problem solving skills and critical thinking abilities.
- Intermediate to Advanced proficiency in Word, Excel, Powerpoint.
- Solid understanding of statistical tools/techniques
- Certified Blackbelt designation.
- Ability to support our transformation to a LEAN enterprise through the application of LEAN tools.
- Proficiency in Trackwise System
- Comprehension/Proficiency of Minitab
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
Thank you for your interest and application to Baxter. All applications will be reviewed and those candidates selected for consideration will be contacted directly.
Baxter is committed to creating and maintaining a barrier-free environment for all employees and customers. We believe in integration and equal opportunity and we are committed to treating all people with dignity and respect.