Quality Assurance Associate

3 weeks ago

Oshawa, Canada Auxilium Health Full time

**ABOUT US**:
***:
The Quality Assurance Associate will be responsible for monitoring and ensuring compliance with company policies, internal procedures and applicable regulations and assisting in the continued development and improvement of the company’s Quality Management System (QMS).

**GENERAL RESPONSIBILITIES AND ESSENTIAL FUNCTIONS**:

- Maintain Standard Operating Procedures (SOPs), Work Instructions (WIs) and Quality Records (QRs)
- Oversee distribution of training on SOPs and WIs and follow up with associates as required to ensure on-time completion of training
- Perform investigations associated with non-conformance events, such as Deviations, Incidents and Complaints
- Perform Vendor Qualification evaluations
- Assist with the initiation, approval and oversight of Change Controls and Corrective and Preventative Actions (CAPAs)
- Assist with the preparation and completion of internal audits and regulatory inspections
- Assist with the preparation of receiving, storage, distribution and recall documentation
- Assist with the monitoring of Key Performance Indicators (KPIs) associated with the QMS
- Assist the Quality Assurance department, as required
- Other duties and projects, as assigned

**QUALIFICATIONS**:

- Experience with Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs)
- Experience with SOPs and quality documentation
- Experience with the requirements and elements of a QMS, including experience with quality processes such as Deviations, Complaints, Change Controls, CAPAs and Audits
- Excellent verbal and written communication skills
- Excellent interpersonal skills and attention to details
- Excellent time management skills, with a proven ability to prioritize and meet deadlines
- Strong analytical and problem-solving skills
- Proficient with Microsoft Office Suite or related software

**EDUCATION AND EXPERIENCE**:

- Bachelor’s degree in a related field (Quality Assurance, Regulatory Affairs, Chemistry)
- 2+ years of experience in a related field (Quality Assurance, Regulatory Affairs, Compliance)

**WORKING CONDITIONS**:

- Office environment
- Siting and working at a computer several hours of the day
- Ability to work alone or on a team
- Ability to work under mínimal supervision

**OUR COMMITMENT TO YOU**:
We are committed to a company culture that motivates collaboration, innovation, and continuous improvement and development. We encourage all employees to share forward-thinking ideas and work at their highest potential.

We support the health and wellness of our employees and offer a flex benefits plan covering medical, dental and vision services.

**_DISCLAIMER_**:

- The job description is not designed to cover or contain a comprehensive listing of activities, duties or_
- responsibilities that are required of the employee. Duties, responsibilities and activities may change or_
- new ones may be assigned at any time with or without notice._

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