Sr. Quality Specialist
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
This position has responsibility for ensuring that CIVA is compliant with cGMP, applicable license and Baxter Quality Management System. This position will direct the implementation, deployment and ongoing continuous improvement of CIVA Quality and support the management of the Baxter quality system within the compounding units. The Sr. Quality Specialist is responsible for ensuring compliance to all applicable Regulatory, Certified Body and Quality System Requirements for CIVA. The role also ensures appropriate risk identification processes are implemented in the compounding units.
Manage the administration of all Quality System activities related to Compliance at the CIVA Centre. This includes development, management, implementation, and maintenance of company policies, Quality Systems and Standards for CIVA; Assure compliance to all applicable Regulatory, Certified Body and Quality System Requirements prior to product release. Collaborate with operations personnel and Quality management to assess quality risk and address compliance gaps. Provide appropriate admixed product disposition in a timely manner. Ensure admixed bathes with associated CAPA/s are provided with disposition prior to completion of batch review.
• Responsible for the implementation of Quality Systems
• Reviews, analyzes and evaluates the quality system through non-conformance management, data trend analysis and routine internal audits to decrease vulnerabilities and to minimize legal and regulatory risk for the corporation.
• Manages the development/revision of current/new Standard Operating Procedures related to the Quality processes
• Manages audit readiness state and host/participates in internal and external audits.
• Direct Quality staff and all Quality activities at CIVA ensuring compliance with Good Manufacturing Practices (GMPs), Baxter Quality Systems and approved Standards and procedures.
• Manage CIVA Quality KPIs and Metrics and Chair Compliance meeting for site
Supplier Quality requirements
• Ensure applicable CIVA suppliers and finished goods/materials are approved in GSQTS
• Evaluate Supplier Corrective Action Report (SCAR) responses
• Track timely closure of corrective/preventative actions
• Perform CIVA supplier quality audit, as needed.
• Perform PEGA sign off of new codes, as needed.
NCR and Change Control
• Chair the CAPA and Change Control review board for site. Provide support for the initiation, assessment, approvals, timely completion and closure of NCRs and Change control in Trackwise 8
• Identify/Implement corrective and preventative actions and evaluate effectiveness.
• Prepare visual metrics and track and trend NCRs and Change controls for WIP and timeliness.
Document, Record management and Batch Review –
• Review, track and process (identify gaps and evaluate impact of changes/requirements) Global Quality Procedures (GQPs) Corporate Quality Procedures (CQPs) for implementation
• Review, track and process CIVA SOP; Prepare annual list of SOPs for review
• Manage and Maintain organization of quality documents and batch records
• Perform the Quality Review of admixtures batch documentation for compliance with current procedures and conformance with Good Documentation Practices.
• Identify non-conformances; timely escalate issues to Quality and CIVA operations management, as needed. Document and address non-conformances prior to providing of release disposition.
• Develop and conduct Quality related training programs (e.g. GMP, GDP, SOPs etc.)
• Log and track complaints. Coordinate the return of complaint samples. Update complaint metrics.
• Liaise with Product Surveillance to effectively process complaints. Manage the return of complaint samples.
• Update Quality metrics for Complaints.
Hold Management and FCA –
• Coordinate the processing of products or materials affected by holds and FCA.
• Support the site Escalation process with appropriate documentation and reporting
• Identify risks on site by routine spot checks and internal audits
• Develop risk assessments and actions plans for risk management on site
• Manage other special projects as required, ensuring all Quality related tasks are completed in conformance with business and regulatory requirements.
• Prepare annual validation schedule and support timely completion of validation activities.
• Provide Quality Support to various CIVA projects.
• Perform other Quality duties as assigned by Manager Quality, CIVA.
• Must have a Bachelor of Science Degree
• Bachelor of Science Degree (Pharmacy or Microbiology)
Major Subjects / Specialties
• Pharmacy, Microbiology
• Chemistry or Biology
Type of Experience
• 3 – 5 years of relevant work experience in a GMP related industry/Quality Operations/Pharmaceutical application
• Strong understanding of Health Canada GMP, ISO 14644, Cleanroom practices, Narcotic Control Regulations (NCR), Food and Drug Regulations Part G(FDR), Medical Device Regulations.
• 3 or more years’ experience in compounding admixtures.
• Prior QA experience in pharmaceutical industry
Years of Experience
• 5 years Quality Experience in GMP related industry/Pharmaceutical applications
• 1 Year of Management Level Experience (direct reports)
• 10 years of Quality Experience
• 3 Years of Management Level Experience (direct reports)
Additional Skills / Special Training / Technical Skills Required
• Organized and analytical approach
• Ability to prioritize multiple tasks
• Ability to work autonomously.
• Strong decision making, critical thinking and problem solving skills
• Ability to proactively initiate and implement continuous quality improvements
• Excellent written, verbal communication and organizational skills
• Working knowledge of Health Canada Regulations and ISO Standards
• GMP knowledge and experience
• Knowledge of parenteral products and their intended use
• Process control orientation
• Lean or Six Sigma
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.