Quality Assurance Associate (Research Data Analyst 3), Lawson - #196368

Lawson

St. Joseph's Hospital - London, ON

Temporary Full Time

Salary Range: $37.24 - $46.56 /hour

Temporary full-time position until approximately September 1, 2030 (with potential for renewal), subject to the availability of work.

The Lawson Research Institute is one of Canada's best and most respected hospital-based research institutes. As the research institute of St. Joseph's Health Care London and working in partnership with London Health Sciences Centre and Western University, Lawson is committed to furthering scientific knowledge to advance health care around the world and to helping people live healthier lives by enhancing our knowledge of preventing, diagnosing, and treating disease.

Lawson is seeking a Quality Assurance Associate for its Cyclotron & Radiochemistry Facility in London, Ontario.

This is a 5-day (37.5 hours) per week position.

The Cyclotron Facility uses a medical cyclotron to produce radioisotopes for Positron Emission Tomography (PET) imaging – the most advanced medical diagnostic imaging technology available today – enabling early and accurate detection of cancer and diseases of the heart and brain.

The Successful Candidate Will Become a Key Part Of a Research/clinical Team In An Academic Hospital Environment, And Will Focus On

• Adherence to GMP regulations by maintaining complete records and ensuring compliance with Health Canada and requirements for sterile pharmaceuticals
• Review of batch files including but not limited to batch records and change controls, and determining the status of deviations
• Creation and revision of standard operating procedures and specifications
• Audits (both internal and by external partners) and regulatory inspections of the facility
• Raw material release, material management, FIFO and vendor qualifications
• Quality investigations, including gathering data and implementing corrective actions (CAPA) where required
  
  

Other Quality Activities

• Document control – issuance of properly formatted, reviewed procedural documents
• Data integrity – review and archiving of original data
• Audit trails – review of paper and electronic equipment logs
• Qualification and Validation – ensure protocols are in line with regulations
• Filing- maintain hard copies of documentation
• Annual product quality reviews
• Ongoing maintenance of existing procedures and documentation
  
  

Other

• Complete other related duties that support the core activities of the Lawson Imaging Program
• Due to the nature of the work, early morning shifts and occasional night coverage are required
  
  

Essential Qualifications

• Completion of a B. Sc. or relevant Quality Assurance college program
• Demonstrated computer proficiency at an intermediate level for Microsoft Word and Excel and a basic level for Microsoft PowerPoint
• Candidate must consent to working in a safe, but radioactive, environment
  
  

Preferred Qualifications

• 2-5 years of experience in a GMP or equivalent regulated environment
• In-depth knowledge of key regulations and guidance documents, pertinent to Product Development and Quality including Health Canada, ICH and ISO, with specific knowledge of the regulations as they pertain to sterile products
• An understanding of the scientific theory behind the syntheses and test methods being reviewed is an asset
• High attention to detail and the ability to maintain accuracy in reviewing batch records, documentation, and regulatory compliance
• Highly organized with ability to manage multiple activities, prioritize effectively, and meet tight deadlines
• Ability to work and problem-solve independently and as an effective team member
• Proficiency in the English language both written and oral with excellent communication skills
  
  

Immunization Requirements

• Provide vaccination records or proof of immunity against measles, mumps, rubella, varicella (chicken pox), Hepatitis B, COVID-19 and influenza.
• Provide documentation of the Tuberculosis skin testing