Quality Assurance Specialist

Quality Assurance Specialist

Requirements

• B.S. degree in scientific discipline including biology, chemistry, engineering, radiochemistry, or physics.
• Previous experience of 2-4 years in pharmaceutical or medical device company is required.
• Experience in reviewing and approving all documentation related to running an effective Quality Management System.
• Experience in reviewing QC analytical and microbiological data.
• Previous experience performing internal audits.
• Familiarization with applicable quality regulations related to pharmaceutical and radiopharmaceutical manufacturing.
• Adequate computer skills/knowledge to perform required job functions.
• Moderate physical activity. Requires handling of average weight objects up to 40 pounds.

Responsibilities

• Review and disposition production batch records.
• Review and disposition documentation related to validation.
• Support and execute records and actions related to the Corrective Action and Preventive Action, Change Control, and Effectiveness Check programs.
• Perform and assess investigations related to process and procedure deviations with applicable impact/risk assessment, root cause analysis, and trend analysis.
• Review Microbiological and QC Analytical Data to ensure it meets all test requirements and data is sound.
• Perform raw material inspection, review, and disposition.
• Participate in the internal audit program.
• Support the document control activities to ensure SOPS, Forms and Work Instructions are kept current.
• Support training activities through assignments in ACE (electronic Quality Management System) and conducting group training as needed.
• Provide reports to support the Quality Management Review initiatives.
• Support remediation actions for identified negative trends in operations and quality control data.

Preferred Qualifications

No preferred qualifications provided.