Our client, a leader in the therapeutics industry, has an immediate opening for a Quality Assurance Specialist. This role will review and approve supplemental logs, charts, and other documents in support of cGMP Operations.

Responsibilities:

• Review batch records for accuracy and completion prior to final release of product
• Perform product releases, specifically fills and intermediates lots
• Coordinate product releases with distributors and customers as needed
• Review and approve incoming materials for release
• Provide quality assurance support for investigations including nonconformance and root cause analysis
• Perform quarterly walkthrough audits of manufacturing and packaging
• Issue, review, and reconcile batch records as needed
• Assist in the maintenance of the Quality System

Requirements:

• Bachelor’s Degree or relevant experience in the life sciences
• 1-2 years minimum experience in the medical device and/or pharmaceutical industries working in a Quality Assurance/Quality Compliance role
• Knowledge of GMP, FDA, ISO requirements
• Requires computer competence, including experience with database and Microsoft Office
• Experience working in a GMP/ISO environment
• Good presentation and organization skills
• Capable of executing tasks per defined policies and procedures to resolve routine issues