Quality Assurance Inspectors work “hands-on” on the production floor, inspecting packaging, labeling and finished products to ensure products comply with Company policies and standard operating procedures (SOPs) and Good Manufacturing Practices (GMP) requirements. Quality Assurance Inspectors are responsible for sampling, inspection and physical testing of packaging components. Quality assurance Inspectors ensure procedures and documentation meet cGMP and Quality standards. As a key support member of a rapidly growing company, the QA Inspector must be flexible in their approach to work and be comfortable with taking on new challenges.
• Perform Quality Assurance tasks including production line clearances, sampling, inspections, and quality attributes testing designed.
• Guiding the production team on quality control measures to improve product excellence.
• Sets up and performs destructive and nondestructive tests on materials, parts, or products to measure performance, or material characteristics.
• Help develop, modify, apply, and maintain quality standards and evaluation methods for products and processes.
• Qualify on visual inspection of in-process materials.
• Perform routine line clearances and in-process inspections in manufacturing.
• Provide oversight of activities on the filling and packaging areas; working with operations personnel to achieve and maintain compliance.
• Monitor manufacturing areas during operations to ensure that batch documentation requirements and SOPs are being followed.
• Review all documentation related to the manufacturing processes for accuracy and compliance, both online and upon completion of the activity.
• Ability to gown to Grade A standards and perform quality inspection inside cleanroom areas.
• Assist with investigations related to non-conformances within manufacturing or during storage.
• Collect representative samples for testing and retention, and ensure all relevant paperwork is complete. Submit samples/resamples to laboratory in a timely fashion to meet production needs.
• Inspect and approve packaging components, manufacturing/packaging rooms, lines and equipment prior to use.
• Sample in-process items and finished products. Perform required inspections and testing of in-process items and finished products.
• Apply disposition stickers to components, in-process materials and finished products.
• Responsible for control of label and inserts during manufacturing activities as well as issuing reports and verifying materials against associated staging sheet.
• Responsible for reconciling unused labels and inserts and their destruction.
• Process and distribute samples to other teams (i.e.: Quality Control Laboratory) for evaluation and testing.
• Ensures all documented data, whether on paper or in an electronic system, follow the principles of ALCOA: Attributable, Legible, Contemporaneous, Original, and Accurate.
• Maintain a clean and safe environment in compliance with State and Federal regulatory guidelines.
• Ability to work with computer-based systems and equipment.
• Perform other duties and responsibilities as assigned.
Associates Degree required. Bachelor’s Degree preferred. Science or engineering degrees preferred. Previous pharmaceutical experience a plus.