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.

Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.