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Quality Assurance Technical Specialist (Stability Program)


Primary Job Responsibilities:


Stability Program


  • Collaborate with third party-testing laboratories, operations, and Aurora locations nationally and globally to understand stability testing requirements and needs; support on-going program improvement
  • Support the creation of SOPs and other necessary documentation for sampling, storage, inventory tracking, and testing processes
  • Ensure that stability testing processes align with Quality SOPs, health and safety procedures, and other relevant company policies and procedures
  • Collaborates with Product Development on sample enrollment. Oversees on-going stability
  • Work with the Operations teams to obtain samples based on production schedules
  • Prepare samples for shipment to third-party laboratory
  • Coordinate with third-party laboratories to ensure that samples are received, and results reported in a timely manner
  • Document analytical results and performs  analysis as needed
  • Document out-of-specification results and collaborate with Product Development, Operations, and Quality teams, to oversee with investigations
  • Compile, interpret, and document statistical data to produce reports and recommendations
  • Maintain records of analytical results, sample inventories
  • Maintain SOPs, and additional documentation as needed
  • Where applicable, must adhere to Aurora’s SOPs and comply with Health Canada’s Cannabis Regulations and Good Manufacturing Practice. In addition, must adhere to ISO 9001:2015 (Quality Management System), ISO 14001 (Environment Management System) and OHSAS 18001 (Occupational Health and Safety Assessment Series).


Technical Quality


  • Assist QA/QC teams with additional functions, including analytical techniques, data analysis and communication to stakeholders, batch record review, routine sample collection / coordination, and interpretation of laboratory results / test methods.
  • Support specification development of new products
  • Assist in the implementation of new projects by manufacturing and Product Development
  • Support the Validation team, QA/QC on statistical trending of data where required
  • Participate in investigations and deviations related to quality control
  • Other duties as required by Quality management

Job Requirements:


  • Bachelor degree in a scientific discipline such as chemistry, biology, pharmacy, math etc.
  • 1-2 years of hands-on work experience in Quality Control or Quality Assurance roles, with preference in Stability testing  and/or  data analysis
  • Previous experience working in a pharmaceutical and/or laboratory environment considered an asset
  • Strong analytical and technical skills
  • A team-player who is willing to learn and can work with cross-functional team members
  • Excellent time management and organizational skills
  • Ability to problem-solve and troubleshoot
  • High attention to detail and ability to perform under dynamic conditions
  • Strong written and oral communication skills
  • Familiar with a broad range of equipment / instruments used in a highly regulated manufacturing environment, considered an asset 
  • Highly organized with strong attention to detail
  • Knowledge in statistical methods
  • Knowledge of computer hardware and software including spreadsheets and word document


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