Gcp Quality Auditor

5 days ago

Montréal, Canada Precision Medicine Group Full time

**Position Summary**:
The Quality Auditor supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures.

**Essential functions of the job include but are not limited to**:

- Process and maintain controlled documents
- Jointly develop and administer training for employees and/or consultants
- Jointly host client/sponsor audits and support regulatory inspections
- Jointly coordinate and conduct assessments/audits of vendors
- Jointly coordinate and conduct internal audits of quality systems
- Jointly coordinate and conduct investigator site audits
- Jointly coordinate and conduct trail master file audits
- Participate in computer systems validation project and systems change control process
- Provide Quality consultation and support to assigned project teams internally and externally
- Support and manage reported quality issues and any associated corrective and preventive
actions
- Monitor quality systems to provide feedback on compliance risks to Quality management and
identify opportunities for improvement
- Maintain Quality trackers, databases, metrics, and files, as required
- Follow applicable regulations and standards, including but not limited to local regulations (US
FDA and EU) ICH, ISO and Precision policies and procedures

**Other duties as assigned**

**Qualifications**:
**Minimum Required**:

- 1+ years industry experience
- GCP familiarity

**Other Required**:

- Availability to travel up to 25% domestically and/or internationally

**Preferred**:

- CRO, Pharmaceutical and/or Medical device experience
- Auditing experience
- Familiarity with Precision SOPs, ICH-GCP and applicable regulations
- Clinical research knowledge

**Skills**:

- Excellent interpersonal and problem-solving skills, effective verbal and written communication, computer skills

**Competencies**:

- Experience in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or
similar database
- Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork,
and a keen attention to detail
- Ability to work independently and in a team environment
- Ability to work with cross functional groups and management under challenging
situations
- Ability to prioritize work and handle multiple and/or competing assignments

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

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