Associate - IAPI QA

Role Summary

The QA Associate – IAPI provides support to Indianapolis API Operations manufacturing and laboratories and ensures quality systems and GMP compliance. The role assists with deviation investigations, change control proposals, procedure revisions, validations and batch dispositions, and is essential for maintaining quality systems and preparation for regulatory inspections.

Responsibilities

• Provide direct quality oversight of production, warehouse/material management, engineering, automation and laboratory operations.
• Review and approve documents including procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations.
• Provide quality guidance and recommendations regarding 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 related to quality systems execution.
• Investigate customer complaints.
• Participate in and/or support recalls, as appropriate.
• Contribute to and review Annual Product Reviews, Quarterly Product and Process Self-Assessments, laboratory periodic reviews and equipment/computer system periodic reviews as appropriate.
• Conduct gap assessments of global requirements and ensure implementation of 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 communication skills.
• Preferred: Strong attention to detail; proficiency with computer system applications.
• Preferred: Knowledge of cGMPs and quality systems.
• Preferred: Understanding of statistical tools and analysis.
• Preferred: Excellent interpersonal and networking skills; 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.

Skills

• Written and verbal communication
• Attention to detail
• Proficiency with computer systems and applications
• Knowledge of cGMPs and quality systems
• Analytical thinking and data interpretation
• Interpersonal and networking abilities

Additional Requirements

• Must complete Learning Plan for Representative – QA – IAPI.
• No certifications required.
• Tasks require entering manufacturing and laboratory areas with appropriate PPE.
• Must support 24 hour/day operations.
• Accommodation requests should be submitted as part of the application process where applicable.