QA Shop Floor

Company: American Laboratories
Location: Omaha
Posted on: May 6, 2021

Job Description:

American Laboratories is seeking a qualified QA Shop Floor Tech to add to our ever growing team! American Laboratories was founded in 1967, based on the knowledge of manufacturing enzymes, proteins and flavors to various industries. Today, American Laboratories employs over 100 people, offers an extensive listing of over 300 products to the Food Processing, Animal Health and Nutritional industries in the United States and 45 countries around the world. Through high quality products and customer service, American Laboratories has become an industry-recognized supplier for the products it manufactures. American Laboratories offers competitive pay, an extensive benefits package and a fun, driven culture. General Description Responsible for ALI Quality Operations and process oversight. Report directly to the QA Supervisor.

• Verify Manufacturing Instructions, batch record and all associated documentation assuring the processes are being performed as required by applicable instruction and written procedures
• Ensure that quality check procedures put in place by the company are followed during every production phase
• Partner with manufacturing to solve quality concerns
• Report quality issues to management
• Provide training to manufacturing technician, supervisor and other personnel as required
• Educate manufacturing team on quality control issues and work with departmental managers to improve overall company product quality
• Conduct/assist investigation process for quality event; identifying root cause and corrective and preventive action
• Support/assist the investigation process of complaint Out of Specification (OOS) and Out of Trend (OOT)
• Verify cleaning process that includes: Pre-Operational Cleaning (POC)/ Pre-Operational Inspection (POI)
• Prepare Swabs in the manufacturing areas (as required)
• Verify Equipment Temperature Logging in the manufacturing areas
• Assist in the inspection, receiving and release of raw materials and components
• Perform Calibrations (as required)
• Perform Product Sampling (as required)
• Update/Review/Approval of Quality System Standard Operating Procedures Additional responsibilities may be assigned as necessary by QA Manager. Shift time is:
  • 9:00am to 6:00pm Qualification requirements
    • Minimum of 3 years of combined experience with USDA and FDA cGMP requirements in a Food / Pharmaceutical environment.
    • Minimum of 3 years of experience with Quality Assurance and/or Quality Control practices in a Pharmaceutical environment.
    • Ability to translate skill and knowledge to others and to interpret regulations
    • Strong understanding of manufacturing process, GMP, documentation and data integrity requirements
    • Experience with computer system and Microsoft programs
    • Possess a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced and diverse product manufacturing environment. Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences. Education Requirements
      • Bachelor's degree in science or appropriate combination of experience and education

Keywords: American Laboratories, Omaha , QA Shop Floor, Other , Omaha, Nebraska