Quality Assurance Specialist Jobs

Essential Duties and Responsibilities

• Identify documentation issues and ensure notification is made to the appropriate personnel
• Participates and/ or generates investigations, root cause analysis, Corrective and Preventive Action (CAPA) plans related to process / product deviations, material testing, and Out-of-Specification events
• Perform batch record review for accuracy, completeness and to identify any potential issues
• Any other duties as assigned
• Performs QA incoming receipt and sampling activities of materials and components
• Performs QA release and line clearance inspections.
• Require to be on-the-floor and present to provide quality oversight for all critical manufacturing and packaging processes and to provide guidance to operations personnel as required.
• Adheres to the Health & Safety Policy and OSHA regulations at all times and to ensure the safety of others in any procedures or tasks performed.
• Coordinate with other departments as required to resolve issues and compliance concerns detected
• Follows, adheres and enforces GLP, GMP, GDP, USP, ICH guidelines, procedures and Policies.
• Performs quality assurance checks on in-process products and finished goods and document results

Qualifications

• QA Systems (QMS, Batch Record Issuance, Validation Issuance, Investigations, CAPA, Close Control, Deviations)
• QA Operations (Batch Record, Release, QA Incoming, QA Testing)
• Experience Supporting Inspections
• 2-3 Years of GMP QA Experience