Quality Associate

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

Job summary

An established industry player is seeking a Quality Associate to enhance their Quality Assurance processes. This role focuses on GMP document management and compliance oversight at a prominent facility. You will be responsible for reviewing batch records and ensuring adherence to quality standards while supporting the resolution of technical issues. This position offers a dynamic work environment where your contributions will directly impact product safety and efficacy. If you have a strong background in GMP documentation and a passion for quality assurance, this opportunity is perfect for you.

Qualifications

• Strong background in GMP documentation and batch record review.
• Experience in resolving technical and compliance issues.

Responsibilities

• Review and approve batch-related documentation for product disposition.
• Support resolution of compliance issues and assist in quality management.

Skills

GMP Documentation

Batch Record Review

Technical Issue Resolution

Education

BS/MS in relevant field

High School Diploma/AS with experience

Job description

The Fountain Group is currently seeking a Quality Associate for a prominent client of ours. This position is located in RTP, NC. Details for the position are as follows:

Job Description:

• GMP DOCUMENT MANAGEMENT – NO TESTING ACTIVITIES
• The Quality Assurance Associate is responsible for contributing to the oversight of key strategic and operational aspects within Quality Assurance at the Research Triangle Park (RTP) facility.
• Activities include, but are not limited to, a review of GMP raw data for compliance.
• The QA Associate 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.
• Job duties include, but are not limited to:
  • Review and approval of batch related documentation (Solution Lot records, Reports, Logbooks, and Release of Autoclaved Equipment) to support product disposition.
  • Transport batch related documentation across RTP buildings to support chain of custody and life cycle management.
  • Support resolution of both technical and compliance issues/gaps of mild to moderate complexity.
  • Assist 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.
  • Complete and maintain related GMP training.
  • Additional job duties that may be assigned from time to time.

Qualifications:

• BS/MS (may consider High School Diploma/AS with extensive relevant experience)
• Strong GMP documentation background
• Review of Batch Records and related documents (lot records, logbooks, technical & compliance issue resolution…)

Compensation: $20-30 an hour depending on education/experience