Quality Assurance Specialist

Education or Equivalent Requirements:

• Quality Assurance Associate
• Bachelor’s degree; OR Associates with 1 year of related work experience; OR High School Diploma/GED with 2 years of related work experience
  
  Job Description:
• Recommend SOP and batch record changes as needed
• Review proposed SOP revisions and provide feedback to management
• Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
• Perform room and equipment clearances per procedure following cleaning conducted by production.
• Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
• Maintain a full understanding of all SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products.