In-Process Quality Assurance Technician (IPQAT)

Responsibilities

• Conduct regular inspections and quality checks of in-process and finished products to ensure compliance with specifications and quality standards.
• Monitor and verify critical control points throughout the manufacturing process.
• Perform line clearance and cleanliness inspections prior to batch production.
• Ensure production areas are free of previous products, components, materials, and documentation before changeovers.
• Review Batch Manufacturing Records (BMRs) and associated documentation for accuracy, completeness, and compliance with Good Documentation Practices.
• Verify Batch History Records and changeover documentation are completed properly and accurately.
• Verify calibration status of equipment, instruments, and measuring devices used in manufacturing.
• Collect, identify, and label product samples according to established sampling plans for laboratory testing and inspection.
• Ensure compliance with cGMP requirements, SOPs, controlled documents, and quality procedures on the shop floor.
• Identify and document quality issues and issue nonconformance reports as necessary.
• Escalate quality concerns to the QA & QMS Supervisor and Quality leadership.
• Place non-conforming products on quality hold or rejected status and ensure proper segregation from acceptable products.
• Participate in root cause investigations and support Corrective and Preventive Action (CAPA) implementation.
• Monitor product rework activities and ensure all rework is performed and documented according to approved instructions.
• Inspect reworked products to confirm they meet customer and quality requirements.
• Provide day-to-day quality oversight and support to manufacturing and operations teams.
• Perform other duties as assigned.

Qualifications

• College degree in Science or a related field preferred; equivalent experience will be considered.
• Minimum of 2+ years of Quality, Quality Assurance, Operations, or Manufacturing experience in a cGMP-regulated manufacturing environment.
• Strong understanding of cGMP requirements and Good Documentation Practices.
• Experience reviewing manufacturing records and quality documentation.
• Familiarity with nonconformance reporting, root cause analysis, CAPA, product holds, and quality inspections preferred.
• Strong attention to detail with the ability to identify aesthetic defects and quality issues.
• Ability to work independently and collaboratively as part of a team.
• Strong written, verbal, and interpersonal communication skills.
• Proficiency with Microsoft Office and database or computer systems.