Quality Assurance Associate (Research Data Analyst 3), Lawson

London Ontario Canada Public Library; London; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading health care institution in London, Ontario is seeking a Quality Assurance Associate to support compliance efforts within their Cyclotron & Radiochemistry Facility. This role involves ensuring adherence to GMP regulations, conducting audits, and maintaining vital documentation. Ideal candidates possess a B. Sc. or relevant Quality Assurance diploma and have experience in a GMP environment. The position is full-time with potential early morning and night shifts.

Qualifications

• Demonstrated computer proficiency at an intermediate level for Microsoft Word and Excel.
• 2-5 years of experience in a GMP or equivalent regulated environment.
• Knowledge of key regulations and guidance documents pertaining to Product Development and Quality.

Responsibilities

• Adherence to GMP regulations and maintaining complete records.
• Review and revision of standard operating procedures and specifications.
• Conducting audits and regulatory inspections of the facility.

Skills

Attention to detail

Organization

Communication skills

Problem-solving

Education

B. Sc. or relevant Quality Assurance college program

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Quality Assurance Associate (Research Data Analyst 3), Lawson

Join to apply for the Quality Assurance Associate (Research Data Analyst 3), Lawson role at St. Joseph's Health Care London

Quality Assurance Associate (Research Data Analyst 3), Lawson

Join to apply for the Quality Assurance Associate (Research Data Analyst 3), Lawson role at St. Joseph's Health Care London

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

Seniority level

Seniority level

Entry level

Employment type

Employment type

Full-time

Job function

Job function

Quality Assurance

Industries

Hospitals and Health Care

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