Quality Assurance Technician

Overview

• Support quality assurance processes for biopharmaceutical manufacturing, ensuring compliance with GMP standards and regulatory requirements.
• Provide QA oversight across manufacturing, validation, materials, QC, engineering, and facility operations.
• Collaborate with cross-functional teams to maintain inspection readiness and continuous improvement initiatives.
• Review and approve documentation, including SOPs, batch records, and quality documents.
• Ensure compliance with cGMP regulations and Good Documentation Practices.
• Support audits and regulatory inspections, providing subject matter expertise and document retrieval.
• Contribute to maintaining equipment calibration and maintenance compliance.
• Assist in deviation investigations, CAPAs, and change controls within the quality management system.

Key Responsibilities & Duties

• Review and approve incoming material documentation for GMP use.
• Provide QA support during manufacturing operations, including area clearance and changeover activities.
• Generate and maintain Quality-related SOPs and controlled forms.
• Review validation documents and protocol executions for regulatory compliance.
• Approve QC laboratory qualification documents, including equipment qualification.
• Perform batch record review and approval to ensure compliance and accuracy.
• Support partner audits and regulatory inspections with document retrieval and expertise.
• Collaborate with teams to drive quality excellence and continuous improvement initiatives.

Job Requirements

• Bachelor’s degree in Biology, Chemistry, Biotechnology, or related field.
• 2–4 years of GMP experience in Quality, Manufacturing, or QC.
• Knowledge of cGMP regulations and Good Documentation Practices.
• Experience with quality systems such as Veeva or SAP is advantageous.
• Strong attention to detail and organizational skills.
• Ability to communicate effectively across teams and departments.
• Proficiency in reviewing and approving quality documentation and validation protocols.
• Commitment to maintaining GMP compliance and inspection readiness.