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.
- 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.
- 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
- Monday to Friday
- QA/Regulatory manufacturing environment: 2 years (Required)
- English (Required)