Quality Assurance Associate

About the role

The Quality Assurance Associate reports to the QA Supervisor and works within a culture of continuous improvement across all GMP‑controlled areas. The role supports product release, deviation management, documentation review, and ensures that cGMP standards are consistently met.

Key responsibilities

• Assess impact of incidents and deviations, conduct batch record reviews, and determine product status (release, reject, hold).
• Perform incoming inspection of printed roll‑stock, labels, inserts, and cartons using statistical sampling plans.
• Investigate product complaints, deviations, and out‑of‑specification results, identifying root causes and corrective actions.
• Conduct internal quality audits and support external HPRA, FDA, and customer audits.
• Review and revise Standard Operating Procedures (SOPs) and related forms.
• Assist with compliance issues on manufacturing lines and ensure SOP adherence.
• Prepare raw material and finished‑product samples for Quality Control testing and verify analysis against specifications.
• Communicate discrepancies, investigations, and trends to management and support continuous‑improvement initiatives.

Required profile

• Experience working in a GMP‑regulated environment, preferably in pharmaceutical or medical device manufacturing.
• Ability to coach operators and supervisors on proper documentation and cGMP requirements.
• Strong analytical mindset with attention to detail and ability to work both independently and as part of a team.

Required skills

• Statistical sampling for label inspection
• Batch record review and release decision making
• SOP writing, review, and revision
• cGMP and GMP compliance knowledge