Job Description

THE QA SHOP FLOOR SPECIALIST WILL BE RESPONSIBLE FOR ALI QUALITY OPERATIONS AND PROCESS OVERSIGHT. 

• Ensure that quality check procedures put in place by the company are followed during all production phases.
• Provide training to manufacturing technician's, supervisor and other personnel as required.
• Colaborate with manufacturing to solve quality concerns.
• Report any quality issues to management.
• Educate manufacturing team on quality control issues and work with departmental managers to improve overall company product quality.
• Verify Manufacturing Instructions, batch record and all associated documentation assuring the processes are being performed as required by applicable instruction and written procedures.
• Conduct/assist investigation process for quality event's; identifying root cause and corrective and preventive action.
• Update/Review/Approval of Quality System Standard Operating Procedures.
• Assist in the inspection, receiving and release of raw materials and components.
• Perform Calibrations and Product Sampling (as required).
• Verify cleaning process that includes: Pre-Operational Cleaning (POC)/ Pre-Operational Inspection (POI).
• Verify Equipment Temperature Logging in the manufacturing areas.
• Support/assist the investigation process of complaint Out of Specification (OOS) and Out of Trend (OOT).
• Additional responsibilities may be assigned as necessary by QA Manager.

Qualifications

• Bachelor's degree in science
• At least 3 years of experience with Quality Assurance and/or Quality Control practices in a Pharmaceutical environment.
• At least 3 years of combined experience with USDA and FDA cGMP requirements in a Food / Pharmaceutical environment.
• Strong understanding of manufacturing process, GMP, documentation and data integrity requirements.

Additional Information

Positions available for OMAHA, NE. 

VALIDATION AND ENGINEERING GROUP, INC IS AN EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER.