Quality Operations 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.
Manage the Quality responsibilities associated with product release per assigned portfolio, including but not limited to:
• Over labeling process (if applicable)
• Sampling and Testing
• Submission Documentation Review
• Documentation Review
• Product release
• Compliance Certificates
• Product Storage and Sample Retention
• Submission of release documentation to regulatory body
• Able to cover release activities for other portfolios as back-up when required.
Liaise with Regulatory Affairs (RA) and Manufacturing sites for the timely receipt of product compliance files, CPIDs, batch records, stability studies, certificates of analysis, certificates of manufacture, APQR summaries, master production documents, MRA certificates, validation summaries and other Quality System documents.
Review, approve and compile annual compliance files.
Complete month end compliance progress summary reports for Management Review as required
Communicate and collaborate with 3PL on issues, deviations and corrective/preventative actions related to product distributed in Canada.
Manage change controls and their associated tasks and evaluate change controls for their impact.
Provide review and support of tasks related to launching of new products.
Initiate and/or approve process and product deviations per applicable quality system. Investigate and implement mitigation actions as necessary.
Evaluate product returns, and provide required product disposition based on available data.
Manage and maintain organization (Filing) of all quality documents.
Evaluate the effectiveness of Quality Standard Operating Procedures and Supplier Agreements and update as required.
Provide product disposition based on available stability data when applicable.
Manage closure of applicable deviation in the timeframe required per applicable quality system. Complete all training requirements.
Project Management :
Direct the global teams on Canadian Quality requirements for new domestic and import products prior to product submission to Health Canada and/or receipt of product in Canada; actively participate as the Canadian Quality representative.
Manage other special projects as required, ensuring all Quality related tasks are completed in conformance with business and regulatory requirements.
Pro-active management for inspection readiness of Canada sites and support of audits/inspections and Support inspections of foreign sites.
• Bachelor of Science or Engineering
• Bachelor of Science or Engineering with additional Post-graduate training and certification in Quality and Regulatory Affairs
Major Subjects / Specialties
• Chemistry, Biology
• Chemistry, Biology, Engineering
Type of Experience
• Prior QA experience in the HealthCare or Pharmaceutical Industry
• Excellent knowledge of GMPs, and Health Canada regulations for drug products, biologics and medical devices
• Manufacturing experience/QA Operations in a GMP Environment
Years of Experience
• 3 years
• 5 years
Additional Skills / Special Training / Technical Skills Required
• Ability to build strong relationships with internal and external customers
• Detail oriented with the ability to work under pressure
• Excellent communication skills
• Time management skills, able to manage multiple projects and priorities
• Must be able to travel between Headquarters and import/distribution warehousing sites
• Decision making skills, dealing with ambiguous situations and customer focus
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.