QA Inspector, 2nd Shift

Overview:

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.

Hours are Monday to Friday, 3:00 pm to 11:30 pm

The ability to read, write and speak English is a requirement of the job.

Responsibilities:

• 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.

Qualifications:

Associates Degree required. Bachelor’s Degree preferred. Science or engineering degrees preferred. Previous pharmaceutical experience a plus.