QA Specialist

Major Responsibilities

• Compliance & Oversight: Ensure that products manufactured at the site comply with approved company policies, quality systems, processes, and regulatory requirements.
• Cross-Functional Quality Support: Provide quality oversight for GMP manufacturing and manufacturing support functions, including Technical Operations, Engineering, Quality Control Laboratory, and Supply Chain activities.
• Document & Operational Review: Review incoming material inspection packages, batch records, manufacturing logs, product changeover/line clearance activities, and manage Quality Logs (e.g., QA Hold, QA Tag Out).
• Batch Release: Perform the release of incoming materials, in-process materials, and finished product batches in accordance with established procedures.
• Investigation Management: Participate in investigations related to deviations, non-conformances, and quality events involving incoming materials, QC testing, manufacturing operations, warehousing, and finished products.
• Change Control: Support and oversee change management activities by serving as Change Coordinator and/or QA representative to ensure changes are appropriately assessed, documented, and implemented in compliance with quality requirements.
• Shop Floor Compliance: Conduct routine GMP walk-throughs of manufacturing, engineering, warehouse, and QC areas to verify compliance with GMP standards and identify opportunities for continuous improvement.
• NPI & Operational Excellence: Support New Product Introduction (NPI), operational excellence initiatives, continuous improvement projects, and other quality-related activities as assigned.