Key Responsibilities:

• Batch Documentation Review: Perform comprehensive quality reviews of batch-related documentation to ensure all issues are resolved prior to product release.
• Batch Disposition: Oversee batch disposition by ensuring that all processes comply with established process controls and regulatory requirements.
• Deviation Management: Initiate, investigate, and resolve product-related deviations in accordance with quality guidelines and regulatory standards.
• CAPA Management: Ensure that all necessary Corrective and Preventive Actions (CAPAs) are initiated, investigated, and resolved efficiently.
• Documentation Management: Generate, update, and maintain quality-related documents, including procedures and forms, to ensure compliance with the latest standards.
• Cross-functional Representation: Act as the QA representative at plant and multi-site scheduling meetings, as well as at disposition meetings, ensuring quality oversight across multiple locations.
• Project Participation: Represent the QA department on various projects and in cross-functional team meetings, providing quality input and ensuring adherence to quality objectives.
• Metrics Reporting: Maintain and report key metrics related to product disposition to support Management Reviews and continuous improvement initiatives.
• Audit and Inspection Support: Participate in and support internal and external inspections and audits to ensure regulatory compliance and adherence to quality standards.

Qualifications:

• Bachelor’s degree in a scientific or technical field preferred.
• Minimum of 3-5 years of experience in quality assurance or quality operations, preferably within a regulated manufacturing environment.
• Strong knowledge of quality management systems, regulatory compliance, and manufacturing processes.
• Experience with batch record review, deviation investigation, CAPA management, and document control.
• Exceptional attention to detail and strong problem-solving skills.
• Excellent communication and interpersonal skills, with the ability to represent QA in cross-functional settings.
• Ability to manage multiple priorities and work in a fast-paced environment.
• Experience with metrics tracking and reporting in support of continuous improvement.

Pay Range: $40/hr to $48/hr