Quality Associate II

The Fountain Group; Whitchurch-Stouffville; On-site; CAD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a GMP Quality Documentation Specialist to ensure compliance and quality assurance in a dynamic pharmaceutical environment. This role involves reviewing critical documentation, supporting compliance efforts, and contributing to the oversight of quality management systems. The ideal candidate will thrive in a collaborative setting, ensuring the safety and efficacy of products while navigating regulatory requirements. If you are passionate about quality assurance and eager to make a significant impact in the pharmaceutical sector, this opportunity is perfect for you.

Qualifications

• Experience in GMP compliance and quality assurance processes.
• Strong understanding of documentation and regulatory requirements.

Responsibilities

• Review and approve GMP raw data and batch-related documentation.
• Support resolution of compliance issues and maintain GMP training.

Skills

GMP Compliance

Quality Assurance

Documentation Review

Problem Solving

Education

Bachelor's Degree in Life Sciences

Relevant Certifications

Tools

Quality Management Systems

Job description

The Fountain Group are a national staffing firm and are currently seeking a GMP Quality Documentation Specialist for a prominent Pharmaceutical client of ours. This position is in Research Triangle Park, NC. Details for the position are as follows:

Job Description:

1. Pay: 25.00-30.00/hr on W2.
2. 12-month assignment to start with potential for extension or conversion.
3. The Quality Assurance Associate II (Contractor) is responsible for contributing to the oversight of key strategic and operational aspects within Quality Assurance at the Research Triangle Park (RTP) facility.
4. Activities include but are not limited to a review of GMP raw data for compliance.
5. The QA Associate II will perform all duties in a manner consistent with site and corporate policies, cGMP, safety, environmental, and human resources policies and procedures, and adhere to all regulatory licenses and regulations, interfacing with key Quality and manufacturing customers.
6. Review and approval of batch related documentation (Solution Lot records, Reports, Logbooks and Release of Autoclaved Equipment) to support product disposition.
7. Transport batch related documentation across RTP buildings to support chain of custody and life cycle management.
8. Supports resolution of both technical and compliance issues/gaps of mild to moderate complexity.
9. Assists Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured.
10. Complete and maintain related GMP training.
11. Additional job duties that may be assigned from time to time.