Quality Assurance Specialist

Location: Must be local in the state of MN

Shift: Monday - Friday 1st shift

Job Description:

This Quality Assurance Specialist will ensure customer satisfaction and cost savings by managing batch records in compliance with cGMP regulations and Quality Assurance Systems.

Responsibilities:

• Review and integrate batch records into the Quality Assurance System.
• Ensure records are complete, accurate, and meet specifications.
• Create certificates of analysis and manufacturing.
• Document and justify deviations and CAPAs.
• Process alerts, deviations, customer complaints, CAPAs, Change Controls/Orders, and Annual Product Reviews.
• Monitor and ensure timely completion of quality system actions.
• Prepare investigations and respond to customer needs accurately and promptly.
• Analyze monthly data to identify trends.
• Implement and maintain lean standards and processes.
• Use lean tools to eliminate waste and improve efficiency.
• Institutionalize 5-S (Sort, Straighten, Shine, Standardize, Sustain).

Skills & Qualifications

• Bachelor's degree in a sciences discipline (Chemistry, Biology, Biochemistry, etc.).
• 2+ years of industry quality experience within a GMP environment.