Quality Assurance Associate

2 weeks ago

Leduc, Canada PBG BioPharma Inc. Full time

PBG BioPharma Inc. is looking to hire a Quality Assurance Associate for our Leduc Alberta location. The position is an important function within our Quality Assurance Department and is responsible for the following.

**Responsibilities**:

- Assists with developing and maintaining the company’s quality systems for manufacturing, packaging, labelling, testing, and release of natural health and/or cannabis/hemp products.
- Ensures quality systems comply with Health Canada regulations and other foreign regulations as needed.
- Develops, reviews, finalizes, and updates Standard Operating Procedures (SOPs), control and monitoring forms among other necessary documentation.
- Reviews production batch records, testing results, and related documents and prepares the required documents for product release.
- Assists with deviation investigations and CAPAs.
- Investigates and responds to complaints.
- Coordinates with production staff to implement and maintain continuous process improvement.
- Assists with preparing and maintaining the Preventative Control Plans (PCPs) for cannabis/hemp product manufacturing.
- Perform quality assurance checks such as GMP, Pre-operational inspections, prerequisite checks, conformity of finished products throughout the manufacturing process, inspect incoming material, etc. to ensure all procedures are fully implemented and to confirm acceptance to required specifications.
- Assists with vendor qualification activities and audits as needed.
- Supports the QAP/designated QAP during audits by regulatory bodies such as Health Canada.
- Supports staff training as needed, coordinates the development of training files for staff, ensures required training is complete and all training records are continually updated and maintained.

**Education and Experience**:

- BSc in Chemistry/Biochemistry/Biology/Food Science or similar discipline.
- 1-2 years experience in a GMP/Pharmaceutical standards compliant environment.
- Experience in Quality Management Systems (QMS), Preventative Control Plans, and Regulatory Submissions will be an added advantage.
- An understanding of Health Canada/FDA regulations and GMP/GPP requirements for any of the following: pharmaceutical, natural health or cannabis products is required.

**Skills**:

- Strong written and verbal (public speaking) communication skills.
- High attention to detail and processes.
- Able to work individually and 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.

**Salary**: From $48,000.00 per year

**Benefits**:

- Dental care
- Disability insurance
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Vision care

Flexible Language Requirement:

- French not required

Schedule:

- 8 hour shift
- Monday to Friday

Ability to commute/relocate:

- Leduc, AB: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (preferred)

Work Location: One location

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