SUMMARY

Working under minimal supervision, the Sr Quality Assurance Specialist-Auditing will work closely with QA and Manufacturing Functional Management to identify strategies, tactics and objectives for product quality and GMP compliance:

• Perform external audits of vendors and suppliers and generate reports providing recommendations on results of audit
• Perform internal audits of GMP and other departments as needed to assess compliance with approved operating procedures and GMP regulations
• Review/Approve/Write/Revise Standard Operating Procedures related to departmental activities
• May act as a mentor, providing general guidance and instructions to less senior members of the team
• Generate trending reports to update management of various department on GMP Compliance status
• Manages receipt, response to and record keeping of product complaints
• Manage the Quality Agreements Program

RESPONSIBILITIES:

• Conducts internal and external audits and works with vendors / internal departments to ensure appropriate responses are submitted in timely fashion
• Manages and tracks corrective actions (CAPA’s) and works with departments on completing them on time
• Works with functional departments in collecting data trends of critical operations within these departments and generated trending reports for cross functional review
• Manages product complaint system
• Helps maintain supplier qualification schedule and vendor status reports
• Assists Training Lead in ensuring training programs are compliant and up to date
• Support preparation of regulatory submissions
• Other assigned responsibilities as established by QA Lead