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Summary 

Responsible for ensuring compliance of Sterility Assurance activities to the Quality Manual, Health Canada, Corporate and ISO requirements. Perform the quality functions at the Center for Intravenous Admixtures (CIVA) as a supervisor, primarily Responsible for: managing the facility Environmental Monitoring program and Sterility Assurance out of limit investigation, leading the Environmental Monitoring Performance Qualification and Real Time Risk Assessment activities, performance and documentation of microbiological Risk Assessment, develop/review of cleanroom validation protocols, performance of disinfectant qualification study and development, support for microbiological/aseptic training program. Provide support to key plant projects as required. Responsible for development and coaching direct reports. As the Function sterility Assurance (FSA) representative, support Sterility Assurance personnel with respect to the global sterility assurance commitments.

Essential Duties

• Manage CIVA's Environmental Monitoring program for cleanrooms and ensure compliance with applicable Baxter Corporate Policies, SOPs and regulatory requirements on cleanroom requirements.
• Will represent CIVA as FSA for site
• Investigate all Sterility Assurance relatedexceptions (i.e. Microbiological OOLs, particulate matter OOLs, and qualification failures etc.)
• Coordinate appropriate follow-up actions and document the appropriate information
• Initiate events in Trackwise 8 and complete CAPA investigations, Manages audit readiness state and host/participates in internal and external audits.
• Lead a cross-functional team in conducting an environmental monitoring performance qualification (EMPQ), Risk Based Life Cycle Management (RBLCM) Process Failure Modes and Effect Analysis (PFMEA) and real time risk assessment (RTRA) per corporate policy requirements
• Perform and document Environmental Monitoring Risk Assessment upon initial facility designs or prior to EMPQ per corporate policy requirements;
• Continuously improve CIVA's Environmental Monitoring program based on test results and risk assessment, Corporate Quality Policies and applicable regulatory standards.
• Maintain the Microbiology lab by coordinating activities with staff, and verifying that appropriate training and certifications programs is up to date.
• Update Microbial Control Scheme and Microbial Quality Plan as required
• Ensure SOPs and Specifications are up to date and procedures are being followed.
• Review SOPs and Specifications regularly, and write new procedures when required.
• 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. Coordinate all activities for Microbial Control Strategy with Global Sterility Assurance for CIVA20%
• Review follow-up actions and test results from all areas as part of all Critical Work performed on site.
• Write and coordinate validations related to new SA equipment, new SA software and method validations.
• Perform sterility assurance impact assessments for product/process changes in TW8 as required.
• Support collection and processing of air (viable/non-viable) surface samples: Obtain air (viable/non-viable) and surface samples from designated sample sites within the facility as part of the Environmental Monitoring program, as required. Conduct the required testing and incubation of these samples in accordance with specifications. Complete documentation required.
• Read and document results of appropriately incubated samples, addressing all microbial out of limits and positive test results, by completing trending analysis (00L investigation), retest procedures, gram staining, process slants for external identification.
• Review and sign off completed paperwork prior to being routed for approval
• Organize data from all areas and prepare and maintain monthly and YTD summaries of sterility assurance data as required.
• Present pertinent data at Monthly Quality Meetings
• Review historical data and determine new EM alert limits
• Ensure trending of environmental data is completed on a quarterly basis
• Manage other special projects as required; ensuring all Sterility Assurance related tasks are completed in conformance with business and regulatory requirements. Communicate with both external and internal customers to ensure that their needs are met. Perform training on site as necessary (ie. GMP, Aseptic technique, sample collection, etc.)
• Conduct regular department meetings with staff and participate in Lab Council Global Sterility Assurance Team meetings. Lead the Sterility Assurance Team and Ensure that action items are completed. - Provide Quality Support to various CIVA projects
• Perform other Quality duties as assigned by Manager Quality,

Qualifications

• Bachelor of Science Degree (Microbiology, Biology)
• 2 to 3 years of relevant work experience in a GMP related Industry / Quality operations / Pharmaceutical applications Preferred:
• Bachelor of Science Degree (Microbiology) - 5+ years of successful supervisory experience over a sterility assurance lab in a pharmaceutical or similar environment Competencies Required: Critical Thinking & Problem Solving - Communication - Business Acumen - Collaboration & Teamwork - Motivating & Developing Others - Dealing with Ambiguity
• Customer Focus
• 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 Preferred:
• GMP knowledge and experience
• Ability to support our transformation to a LEAN enterprise through the application of LEAN tools.

Reasonable Accommodations

Baxter 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.