Specialist-I, QC Chem

This is where you save and sustain lives

At 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.

Summary of responsibilities
The Specialist-I, QC Chem role at Baxter Healthcare Corporation offers an outstanding opportunity to work within a world-class team, driving innovation and excellence in quality control. You will support the execution of the Validation Master Plan and Change Control associated with Data Integrity for the Alliston facility. This position involves preparing, executing, and detailing data integrity computer system validation protocols in strict accordance with Corporate Quality Policies, Health Canada, and ISO requirements. You will manage the installation and qualification of diverse laboratory equipment/software, collaborating with a diverse team to achieve maximum results in minimum time.

General expectations
The top two priorities for all Baxter Alliston employees are Safety and Quality:

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 guarantee 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 timely
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 Projects)
Embracing continuous learning
Applying Leader Standard Work
Using Root Cause Analysis tools to identify and prevent problems from recurring and drive measurable results
Essential duties and responsibilities
Time Spent

Major Responsibilities / Activities
80%

Design IQ/OQ/PQ and validation campaigns as well as develop, prepare, and write the protocols for equipment/software validation
Coordinate validation and IQ/OQ/PQ activities among Quality Control Laboratories and outside contractors, providing leadership, training, and mentorship
Monitor and support the execution of the protocols through training, facilitating, and problem-solving activities
Perform retrospective validation packages as required for legacy systems and processes
Prepare or assist in the preparation of Validation Maintenance packages
15%

Provide support for the Quality technical review/approval of department-related procedural changes and validations/protocols
Stay current with respect to regulatory trends and divisional issues related to their area of expertise
Partner with facilities, divisions, and regions to ensure knowledge sharing and successful implementation of Quality improvement initiatives
5%

Complete requested month-end summary/metric reports for Management Review meetings
Ensure activities in Baxter Quality Plans are completed, identify opportunities, and craft action plans.
Job requirements
Education Level

Required:
Bachelor of Science or equivalent experience in IT/Computer Science or Bachelor of Applied Science/Engineering (Computer Software/Systems)
Major Subjects / Specialties
Required:

Science (Chemistry, Microbiology, Pharmacy, Engineering)
Type of Experience
Required:

Laboratory Equipment and Computer System/Software Validation experience
Manufacturing & Quality background
Previous experience in a GMP environment
Knowledge of GMP, ISO, and Regulatory standards
Preferred:
Knowledge of Corporate Quality requirements
Years of Experience
Required:

2 – 3 years of experience in a pharmaceutical environment
Preferred:
5+ years of successful experience in a pharmaceutical environment
Additional Skills / Special Training / Technical Skills Required
Required:

Strong understanding of Health Canada GMP and Medical Device Regulations
Detailed knowledge of applicable procedures, specifications, regulations, and standards
Strong process and project management capabilities
Strong written and oral communication skills, negotiation skills, and the ability to work with all levels of the organization
Ability to cultivate positive 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, and PowerPoint
Solid understanding of statistical tools/techniques
Preferred:
PMP Courses or Certification
Ability to support our transformation to a LEAN enterprise through the application of LEAN tools
Proficiency in Trackwise System
Comprehension/Proficiency in Minitab
Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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Canada
Ontario
Alliston Show on map Get directions