Quality Assurance and Regulatory Affairs Associate – PBG BioPharma Inc

Quality Assurance and Regulatory Affairs Associate

PBG BioPharma Inc. is looking to hire a Quality Assurance and Regulatory Associate for our Leduc Alberta location. The position reports to the Vice President of Product Development and is responsible for the following.

Job Responsibilities:

  • Assists with developing and maintaining highly organized quality systems for manufacturing, packaging, labelling, testing, and release of natural health and cannabis/hemp products.
  • Prepares, finalizes, and updates policies, procedures, and record forms related to these quality systems.
  • Assists with preparing and maintaining Preventative Control Plans (PCPs) for cannabis/hemp product manufacturing.
  • Coordinates the development of training files for all staff, ensures required training is complete and all training records are continually updated and maintained.
  • Supports staff training as needed.
  • Helps prepare certification applications required for Natural Health and Cannabis product manufacturing and distribution in Canada as well as other countries as needed.
  • Supports the reporting of incidents or adverse events to regulatory bodies and maintenance of the company’s pharmacovigilance system.
  • Ensures accurate record keeping and filing as per organizational procedures.
  • Assists with tracking metrics related to compliance and efficiency of the quality systems and provides recommendations for improvement.

Education and Experience:

  • BSc/MSc in Chemistry/Biochemistry/Biology/Food Science or similar discipline.
  • 2-3 years experience in a QA/Regulatory manufacturing environment.
  • Experience Quality Management Systems and Preventative Control Plans, and Regulatory Submissions.
  • An understanding of Health Canada/FDA regulations and GMP/GPP requirements for any of the following: pharmaceutical, natural health or cannabis products.

Skills:

  • Strong written and verbal (public speaking) communication skills.
  • High attention to detail and processes.
  • Able to work individually or as part of a team.
  • Able to multi-task efficiently.
  • Creative thinker.
  • Excellent organizational skills.
  • Able to communicate well across disciplines.
  • Works well in a fast-paced environment with changing multiple priorities and frequent interruptions.
  • Able to follow direction.
  • Efficient with computers and computer programs.

Job Type: Full-time

Schedule:

  • Monday to Friday

Experience:

  • QA/Regulatory manufacturing environment: 2 years (Required)

Language:

  • English (Required)

Work remotely:

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