QA Specialist

6 days ago

Coquitlam, Canada IQR Consulting Full time

The Quality Assurance Specialist will support the Quality Assurance Senior Consultants in fulfilling their roles to the clients by working closely and communicating regularly with the Senior Consultants with respect to the required work to be done. Quality Assurance Senior consultants at IQR Consulting Ltd. are responsible for providing quality and regulatory support to clients in the natural health product, food, cosmetic, pharmaceutical, medical device and cannabis industries.

This position will report to the Primary Consultant / President and will support the other Senior Consultants through the direction of the Primary Consultant / President.

The Quality Assurance Specialist role requires strong verbal and written communication skills, proactive attitude, strong organization skills, excellent time management, problem-solving, strategic thinking, teamwork, flexibility and an eager to learn attitude. This position includes helping the Senior Consultants in establishing and maintaining aspects of clients’ quality systems as required including but not limited to the following:

- Managing all open investigations or corrective actions
- Support identification, investigating and logging to completion:

- Complaints
- Adverse Reaction reports
- Non-conformances
- Deviations
- OOS
- CAPAs
- Preparing and Completing the following:
1. Risk analysis

2. Change controls

3. Recalls (assisting the Senior Consultant where required)
- Mock recalls
- Quality Trending Reports
- Self-Inspections for clients
- Annual Summary Reports (for Adverse Reactions)

4. Initial reviewer of finished products requiring release

5. Setting up and maintaining material and product specifications

6. Setting up and maintaining label masters

7. Perform label reviews (Canadian NHPs, US Dietary Supplements)

8. Assisting in maintenance of retained samples for clients that require this activity

9. Review and maintain temperature monitoring reports for clients that require this activity

10. Communicate with third party laboratories in obtaining quotes for client testing; preparing test requisition forms and arranging for obtaining samples and sending out to the third-party laboratories (for regular testing and stability testing)

11. Assisting Senior Consultants with setting up stability studies and subsequently keeping track of testing time points, reviewing results and following up on any required investigation, updating the stability summary reports and preparing the final stability report

12. Assisting Senior Consultants with establishing and reviewing quality agreements

13. Assisting Senior Consultants with conducting audits and participating in regulatory authority audits for clients

14. Assisting Senior Consultants with providing training to clients and their employees, as required

15. Maintaining client quality and regulatory files as required, both electronically and physically

16. Manage product holds, reprocessing actions and assess product quality risk as needed in determination of final product disposition

17. Maintain initial and ongoing training on required SOPs and GMPs

Qualifications:

- Bachelor’s Degree in Science (equivalent to Canadian requirements)
- Direct work experience with QA systems in the NHP and/or pharmaceutical industries (at least 3 years)
- QA experience in manufacturing
- Knowledge of Health Canada GMP regulations for Natural Health Products, foods and Pharmaceutical Products
- Excellent computer skills including proficiency with MS Excel, Word and Outlook
- Chemistry and microbiology knowledge an asset
- Ability to work and make decisions in a dynamic and fast-paced environment
- Ability to present information and communicate with clients and colleagues in a clear way
- Detail-oriented with proven analytical and problem-solving skills
- Highly developed organizational and time management skills with the ability to prioritize and manage a diverse number of projects. Strong project management skills.

**Job Types**: Permanent, Full-time

**Salary**: $50,000.00-$55,000.00 per year

**Benefits**:

- Dental care
- Extended health care
- Flexible schedule

Schedule:

- 8 hour shift

Work Location: In person

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