GBP Quality Assoc II

** Hours* Sunday - Thursday - 10:00 pm - 7:00 am**

• Conduct various Quality audits (SCR, Trailer Inspections, Process Audits), identify issues, and maintain cGMP compliant documentation of such activities.
• Work closely with Production, and Quality Manager to correct issues found prior to the shipments of loads.
• Work closely with Production to correct cGMP-GDP issues found in Shift-to-Shift Batch Record Reporting prior to final Batch Review.
• Ensure completion of Annual Weight Calibration for Quality specific weights.
• Inspection of in-process 50lb bags and 2000lb Super Sacks.
• Communicating issues found in Production as they arise.
• Customer Specific Testing (Bulk Density)
• Liquid Load Testing (In-Process Testing)
• In-Process Testing & Data Reporting (Bulk Density, Mud pH, etc.) 
• Maintain Compliance and Issues Found in reporting Spreadsheets
• Maintain Metal Contamination Prevention Program
• Ensure completion of Annual Compact Force Gauge (Magnet Strength Tester) Calibration
• Conduct Semi-Annual Magnet Strength Tests of necessary equipment.
• Conduct non-conforming product audits (Collect Data, Write Reports, and Communicate to necessary individuals)
• Maintain Temperature and Humidity Data
• Assist with preparation for  Regulatory Agencies, 3rd Party Certifications, and Customer Audits

Perform other duties, as needed, based on evolution of the company and the requirements of the department/position.

• • Fundamental understanding of cGMP and Safety regulations.
  • Ability to influence people; must be able to drive results via influence rather than direct authority.
  • Ability to repeatedly lift/turn 50lb bags.
  • Ability to stand for long periods of time while conducting audits, inspections, and testing.
  • Ability to work overtime and one day per weekend as production and shipping schedule demands.
  • Possess oral and written communication skills, strong interpersonal skills, strong organizational abilities, and able to work in a team environment.
  • Must have strong personal time management skills with ability to work with minimal supervision and must have Multi-Task capabilities.
  • Intermediate computer skills (Microsoft Word and Excel).
  • Previous Quality Auditing experience a plus.
  • Background in medical, food, or pharmaceutical manufacturing a plus.

Education (minimum requirements/equivalent):  

• High school diploma required. Degree in scientific or technical field preferred.
• Two years’ work experience in Quality Assurance/Quality Control and/or in a regulated Manufacturing environment needed. Further experience may be considered in lieu of education.
• Certification as a CQA is highly desirable.