QA Compliance Analyst

About Resolute

We have been retained by a pharmaceutical manufacturing company to support its increased production demands through the provision of qualified resources at its manufacturing facility in Brantford, Ontario. All positions associated with this engagement are site-based and require personnel to work on-site. Please review the site location and associated logistics, including commuting arrangements, accessibility, and any site-specific requirements, when considering these opportunities.

We are looking for a highly motivated and energetic professional to join our team as a QA Compliance Analyst in Brantford, ON (Onsite). This is a contract role. 

• Develop, implement, and maintain departmental procedures, analytical test methods, and quality systems in compliance with GMP and applicable regulatory requirements.
  
• Oversee daily Quality Assurance and Quality Control operations, including staff supervision, training, work assignments, performance management, and departmental budgeting.
  
• Manage quality compliance programs, including Change Control, Deviations, CAPA, internal audits, and supplier audits.
  
• Oversee final product release, product recalls, returns, customer complaints, and approval of analytical methods, SOPs, and controlled documents.
  
• Ensure regulatory compliance, coordinate regulatory audits, prepare audit responses, and maintain effective calibration and preventive maintenance programs.
  
• Oversee monthly and annual product quality reviews, recommend quality improvements, and collaborate with Production, customers, and other departments to ensure quality standards are met.
  
• Ensure compliance with GMP, company policies, occupational health and safety requirements, and documentation practices while driving regional and global quality initiatives in collaboration with the Director of Quality and performing other assigned duties.
  

• Bachelor’s degree in Chemistry, Microbiology, or a related scientific discipline from a recognized accredited institution.
  
• Minimum 7 years of experience in Quality Assurance, Quality Control, and Validation within a pharmaceutical manufacturing cGMP environment.
  
• Strong knowledge of pharmaceutical validation requirements, including process, cleaning, and computerized systems validation, as well as GMP/cGMP and GLP regulatory standards.
  
• Relevant quality certification from a recognized organization, such as the American Society for Quality (ASQ), is an asset. Proficiency in MS Office and Smartsheet is preferred.
  
• Strong organizational, time management, multitasking, and problem-solving skills, with the ability to manage competing priorities and work effectively under pressure.
  
• Excellent interpersonal, verbal, and written communication skills, sound judgment, and a commitment to continuous improvement when working with internal teams and external stakeholders.
  
• Must be available for after-hours on-call duties and occasional emergency overtime; position is classified as overtime-exempt.