- Following all safety procedures
- Understanding potential hazards in your area
- Wearing appropriate PPE
- Reporting all incidents / near-misses / concerns
- Embracing 6s
- Following Good Manufacturing Practices (GMP)
- Adhering to all quality procedures
- Completing training on-time
- Doing it Right the First Time
- Reporting any quality concerns immediately.
- Participating in improvement activities
- Identifying and implementing continuous improvement ideas
- Participating in Tier meetings
- Recognizing your peers
- 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.
- Investigate all Sterility Assurance related exceptions (ie. Microbiological OOLs, particulate Matter OOLs, aberrations, missing data, customer complaints and sterilizer qualification failures etc.) Coordinate appropriate follow-up actions and document the appropriate information.
- Initiate events in Trackwise 8 and complete CAPA investigations as required.
- Review follow-up actions and test results from all areas as part of the Critical Work Request (CWR) process.
- Write and coordinate validations related to sterilization, new SA equipment, new SA software and method validations.
- Perform sterility assurance impact assessments for product/process changes in TW8 as required.
- Review and sign paperwork generated from the following areas:(1)Environmental Lab (daily solution bioburden, weekly, monthly, quarterly and semi-annual EM testing results, device bioburden testing, dose audit results, growth promotion test results and laboratory preventative maintenance);(2)Particulate Matter Lab (ie. Clean room garment results, stability samples and laboratory preventative maintenance);(3)Pyrogen Lab (ie. Peptidoglycan test results, Stability samples, raw materials and laboratory preventative maintenance)
Sterilizer Quals Lab (ie. Qualification studies, cycle development for new or revised loading patterns, calibrations/verification, vessel qualification sheets, 6-month vessel qualification sheets, 2-year qualification expiration sheets, BMTS tables and laboratory preventative maintenance). - Maintain the Particulate Matter, Pyrogen, Quals and Environmental labs by coordinating activities with staff, and verifying that appropriate training and certifications programs for personnel is appropriate up to date.
- Ensure SOPs and Specifications are up to date and procedures are being followed. Review SOPs and Specifications regularly, and write new procedures when required.
- Establish Employee PMOs based on plant objectives. Conduct performance reviews and salary adjustments.
- Maintain an audit ready state in all areas. Participate in internal and external audits. Correct and resolve identified audit items.
- Identify opportunities for improving testing procedures and/or equipment and implement these changes.
- Advise personnel on procedures and be prepared to trouble-shoot when necessary.
- Communicate with both external and internal customers to ensure that their needs are met. Perform training in the plant as necessary (ie. GMP, sample collection, etc.) Conduct regular department meetings with staff and participate in Lab Council Team meetings.
- Lead the Bioburden Team and ensure that action items are completed.
- Organize data from all areas and prepare and maintain monthly and YTD summaries of sterility assurance data as required.
- Present pertinent data at Monthly Plant Quality Meetings
- Review historical data and determine new EM alert limits
- Ensure trending of environmental data is completed on a quarterly basis
- Complete quarterly notebook reviews in all areas, maintain appropriate stock of equipment and supplies, and ensure appropriate permits (ie. Alcohol, permit for importing pathogens) are valid.
- Initiate departmental work orders, coordinate shutdown testing arrangements and a coordinate vendor calibrations and Preventative maintenance.
- 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.
- University Degree, Bachelor of Science (Major in Microbiology or Biology)
- 2-3 years of experience in a sterility assurance lab environment
- Previous experience in a GMP environment
- Previous Sterility Assurance lab experience
- People management experience including the ability to motivate and mentor
- In-depth knowledge of GMP, ISO and Regulatory standards
- Strong understanding of Health Canada, GMP and Medical Device Regulations.
- Thorough knowledge of applicable procedures, specifications, regulations and standards.
- Strong understanding of aseptic techniques.
- 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.
- Masters Degree or Ph.D
- 5+ years of successful supervisory experience over a sterility assurance lab in a pharmaceutical or similar environment
- Strong understanding of terminal sterization
- Ability to support our transformation to a LEAN enterprise through the application of LEAN tools.
- Proficiency in Trackwise Systems
- Knowledge of Corporate Quality requirements
- Practical experience using Lean tools (6S, Kaizen, Value Stream Mapping).
- Previous experience with Terminal sterilization validation
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Description
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.
Your Role at Baxter:
In this role, you will be responsible for ensuring compliance of the following Sterility Assurance activities to the Quality Manual, Health Canada, Corporate and ISO requirements: Pyrogen (LAL) testing, Particulate Matter testing, Environmental Monitoring, Sterilizer Qualifications, Sterility Testing, Laboratory Maintenance. You will ensure that nonconformance events and CAPA investigations under areas of responsibility are performed and mitigating actions are identified and implemented. Review for all Sterility Assurance OOL investigations. Provide support to key plant projects as required. Ensure that all Preventative Maintenance, Calibration, and Validation activities are completed in full compliance and on schedule. Provide support for the Quality technical review/approval of department related procedural changes. Responsible for recruiting, training, and coaching all direct reports.
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:
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:
As part of the plant's Enterprise Management System (EMS ), all employees must embrace a culture of Continuous Improvement by:
What you'll be doing:
What you'll be having:
Nice to have:
#LI-BAXGEN
