Quality Assurance Associate

4 days ago

St Catharines, Canada Biolyse Pharma Full time

Biolyse Pharma
**Situated in St Catharines, Biolyse Pharma is a sterile manufacturing company that produces oncology products.**
**Biolyse is searching for professional and talented individuals who are enthusiastic, goal oriented and focused on their future career. We look forward to hearing from you soon.**

Education and Experience:

- Bachelor's degree in a relevant scientific field, such as chemistry, pharmacy, biology, or a related discipline.
- Previous experience working in a GMP-regulated industry, such as pharmaceuticals, biotechnology, medical devices, or food manufacturing, with a focus on quality assurance.
- Familiarity with GMP regulations and guidelines, such as FDA regulations, EU GMP, or ICH guidelines.
- Experience in conducting GMP audits, inspections, and quality risk assessments.

2. Knowledge of GMP:

- Understanding of GMP principles and practices, including documentation control, batch record review, deviations, CAPA, and validation processes.

3. Quality Assurance Skills:

- Understanding of quality assurance processes, including quality control testing, quality investigations, and quality documentation.
- Experience in preparing for and participating in regulatory inspections and audits.

4. Communication and Collaboration:

- Excellent written and verbal communication skills to effectively communicate with cross-functional teams, regulatory authorities, and external stakeholders.
- Strong interpersonal skills to collaborate with colleagues at all levels of the organization and facilitate effective communication between departments.

5. Problem-Solving and Analytical Skills:

- Ability to identify root causes, and propose practical solutions.
- Problem-solving skills to address quality issues and implement preventive measures.

6. Computer Skills:
**Job Types**: Full-time, Permanent

**Salary**: From $21.00 per hour

Day range:

- Monday to Friday

Shift:

- 8 hour shift
- Day shift

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- Quality Assurance: 1 year (preferred)

Work Location: In person

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