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Quality Assurance Specialist

2 months ago

Toronto, Canada dicentra Full time

Welcome to dicentra

Let’s build a better world, together

**Why join us**

**Best workplace**:

- We nourish an environment devoted to honesty and fairness, trust and respect. We care deeply for our team members and take work-life balance seriously, allowing our people to decide on a schedule that best fits their life and working preferences._

**Best people**:

- We unite cross-industry professionals with a shared passion for improving people’s health and wellness. Our inspiring leaders are accessible and work eagerly side-by-side with individual employees to help them understand and achieve their objectives._

**Best opportunities**:

- We encourage our team members to continuously develop and enhance their skills and expertise. We recognize and reward courageous choices and innovative ideas that result in the growth of our people and company, and in the success of our clients._

**Become a part of a purpose-driven and future-oriented business that impacts and improves millions of lives worldwide**

**Description**:
The Quality Assurance Specialist is mainly responsible for overseeing the importation of Natural Health Products, preparation of Product Master Files/Quality Summary Reports and NNHPD Finished Product Specifications (FPS) as well as incorporating new products into the Quality Management System.

**Roles and Responsibilities**:

- Continuous review of imported product samples and labels.
Review of documentation for the release of imported products including Certificates of Analysis (C of A), Certificates of Manufacture (C of M), Receiving Records, Batch Records, OOS/laboratory test reports.
- Liaise with clients to request product release documentation, communicate discrepancies, provide updates, and respond to questions to ensure a smooth/timely product release process.
- Prepare product review and release reports and label review reports.
Develop, recommend and monitor corrective actions when issues with the imported products arise.
- Review and approve product destruction and return reports.
Determine testing requirements and justifications for testing.
Prepare NNHPD FPS submission documents based on approved QSRs.
Review of label artworks.
- Prepare Quality Summary Reports and revise Standard Operating Procedures.
- Identify areas of improvement and address/implement changes to improve processes and documentation.
- Management of assigned accounts.
- Review, manage, and respond to ePost communications. Handling all ePost communications with the NNHPD on behalf of dicentra.
- Liaises between clients and government agencies in both Canada and the USA to ensure all stakeholders have accurate information and a clear understanding of quality and regulatory requirements related to importation and GMP.
- Complete the Quality Section of Product Licence Applications (NHPs) and GRAS dossiers.
- Other ad hoc tasks within the department based on experience and availability to assist.
- Preparing International Trade Certificates.

**Qualifications**
- Bachelor’s degree in the health sciences or similar discipline.
- Post-graduate training/education in a formal Regulatory or Quality Assurance program is an asset.
- Minimum five (5) years of experience within the pharmaceutical/Natural Health Product industry with a minimum three (3) years in a quality function role.
- Excellent organization and multi-tasking skills.
- High level of attention to detail.
- Good collaborative interpersonal skills, a positive can-do attitude, and problem-solving capabilities.
- Ability to work independently and prioritize with mínimal daily instruction.
- Proficiency in MS Office.

**Job Type**: Full-time

**Location**: Toronto, Ontario (Remote)

**Applying**:
We thank all applicants for their interest, however, only those selected for an interview will be contacted.

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