Associate - Quality Assurance IAPI

Role Summary

The Associate – QA – IAPI provides support to Indianapolis API Operations manufacturing and laboratories and ensures quality systems and GMP compliance. The QA Associate provides assistance and guidance in deviation investigations, change control proposals, procedure and master production revisions, validations and batch dispositions. The QA Associate’s position is essential for maintaining quality systems, ensuring GMP compliance and in the preparation for inspections by various regulatory agencies.

Responsibilities

• Provide direct quality oversight of production, warehouse/material management, engineering, automation and laboratory operations.
• Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations.
• Provide quality guidance and recommendations with regard to manufacturing, materials, utilities, maintenance and laboratory issues.
• Participate in aberrant data investigations.
• Conduct analytical data review including stability data.
• Disposition API Intermediates and raw materials, as appropriate.
• Provide coaching, feedback and mentoring to QA Specialists as it relates to execution of quality systems.
• Investigate customer complaints.
• Participate in and/or support recalls, as appropriate.
• Contribute to and review Annual Product Reviews (APR), laboratory periodic reviews and equipment/computer system periodic reviews, as appropriate.
• Conduct gap assessments of global requirements and ensure implementation of the governing standards.
• Participate in and/or lead self-inspection activities.
• Participate in and/or support regulatory inspections and audits.
• Maintain and improve quality systems.
• Assist others in the interpretation of regulatory and corporate requirements.

Qualifications

• Required: BS in Engineering or a science-related field or equivalent experience.
• Preferred: Experience with computer system validation.
• Preferred: Demonstrated strong written and verbal communications skills.
• Preferred: Strong attention to detail.
• Preferred: Proficiency with computer system applications.
• Preferred: Knowledge of cGMPs and quality systems.
• Preferred: Understanding of statistical tools and analysis.
• Preferred: Excellent interpersonal skills and networking skills.
• Preferred: Ability to organize and prioritize multiple tasks.
• Preferred: Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs.

Education

• BS in Engineering or science-related field or equivalent experience.

Additional Requirements

• Must complete Learning Plan for Associate – QA – IAPI.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
• Must support 24 hour/day operations.