Sr. Associate/Principal Associate - External Manufacturing API Quality Assurance

Role Summary

The API EM Quality Associate provides support to all quality activities at Contract Manufacturing organizations (CMs), ensuring that all batches meet specifications, are manufactured per the validated process, and comply with cGMPs and regulatory commitments. The role involves daily interaction with external partner teams and site management. Location: Indianapolis, IN; onsite with relocation support available.

Responsibilities

• Serve as a quality liaison between CMs and Lilly.
• Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
• Escalate quality issues at CMs to Lilly QA management.
• Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
• Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
• Provide quality oversight of Lilly/APIEM Quality Plans.
• Coordinate and perform QA responsibilities of API shipments.
• Participate in regulatory inspection preparations with CMs and provide on-site support during inspections.
• Participate on the Technical Review Board.
• Evaluate and disposition API batches, if required.
• Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
• Provide quality support of API manufacturing with a holistic review of key activities affecting manufacturing processes including deviations, change controls and countermeasures.
• Assess the impact of deviation investigations and changes and ensure appropriate records are documented and retrievable.
• Ensure all processes are in an appropriate state of control.
• Maintain awareness of external regulatory agency findings referencing product quality.
• Review and approve documents including procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, and computerized system validations.
• Participate in APR activities and projects to improve productivity.
• Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.

Qualifications

• Required: BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
• Required: 5+ years of GMP manufacturing knowledge and/or experience in API or finished product manufacturing.
• Preferred: Experience in quality support for Quality Control activities.
• Preferred: Thorough technical understanding of quality systems and regulatory requirements.
• Preferred: Knowledge of pharmaceutical manufacturing operations.
• Preferred: Demonstrated coaching and mentoring skills.
• Preferred: Experience in root cause analysis.
• Preferred: Demonstrated application of statistical skills.
• Preferred: Strong written and verbal communications skills.
• Preferred: Strong attention to detail and proficiency with computer system applications.
• Preferred: Excellent interpersonal and networking skills; ability to organize and prioritize multiple tasks; ability to influence diverse groups and manage relationships.

Skills

• Quality systems and regulatory requirements
• Documentation review and approval
• Deviation and change control management
• Regulatory inspection readiness
• Analytical and problem-solving skills
• Communication and collaboration with external partners
• Project and process improvement

Education

• BS in Pharmacy, Chemistry, Biological Sciences or related Life Sciences

Additional Requirements

• Must complete required training for API EM Quality Assurance.
• Must be able to support 24 hour/day operations.
• Onsite role in Indianapolis, IN; not approved for remote work. Relocation support provided.