QA Dry External Intermediates Manufacturing Associate

Role Summary

QA Dry External Intermediates Manufacturing Associate synthesizes quality assurance activities for contract manufacturing of intermediates, ensuring batches meet specifications, are produced per validated processes, and comply with cGMP and regulatory commitments. The role acts as a liaison between contract manufacturers and Lilly, supporting quality oversight and regulatory readiness related to Dry EM processes.

Responsibilities

• Serve as a liaison between contract manufacturers and Lilly.
• Provide quality oversight of contract manufacturers, including being the initial contact for quality-related issues.
• Escalate quality issues at contract manufacturers to Lilly QA management.
• Assist in establishing and revising Quality Agreements with affiliates and customers.
• Ensure compliance with Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
• Provide quality oversight of Lilly/Dry-EM Quality Plans.
• Coordinate and perform QA responsibilities of API shipments.
• Participate in regulatory inspection preparations with contract manufacturers and provide on-site support during inspections.
• Participate on the Technical Review Board.
• Evaluate and disposition batches of intermediates as required.
• Ensure documented checks for Certificates of Testing, Certificates of Environmental Monitoring, deviations, changes, and batch documentation demonstrate requirements are met prior to batch release.
• Provide quality support of the manufacturing process for intermediates (e.g., Spry dry dispersion) with focus on deviations, change controls, and countermeasures.
• Assess the impact of deviation investigations and changes; ensure 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 productivity improvement projects.
• 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: 3+ years of GMP manufacturing knowledge and/or experience in API/intermediates or finished product manufacturing, QC, QA or Engineering.
• 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; proficiency with computer system applications; excellent interpersonal and networking skills.
• Preferred: Ability to organize and prioritize multiple tasks; ability to influence diverse groups and manage relationships.

Education

• BS in a science-related field (required).

Additional Requirements

• Must complete required training for Dry-EM Quality Assurance.
• No certifications required.
• Must be able to support 24 hour/day operations.
• Willingness to travel, expected 30% travelling.