The QA Associate is responsible for ensuring all batches meet specifications, are manufactured in accordance with the validated process, and are compliant to cGMPs and regulatory commitments.
Detailed responsibilities:
• Providing quality oversight of CMs including being the initial point of contact for all quality-related issues.
• Escalating quality issues at CMs to Lilly QA management.
• Assisting in the establishment and revisions of Quality Agreements with affiliates and customers.
• Providing quality oversight of Lilly/APIEM Quality Plans.
• Coordinating and perform QA responsibilities of API shipments.
• Participating in regulatory inspection preparations with CMs.
• Providing on-site support during manufacturing events and inspections.
• Participating on the Technical Review Board.
• Evaluating and dispositioning of API batches, if required.
• Ensuring 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.
• Providing quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
• Assessing the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
• Ensuring all processes are in an appropriate state of control.
• Maintaining awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
• Reviewing and approving documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, and computerized system validations.
• Participating in APR activities.
• Participating in projects to improve productivity.
Basic Requirements:
• BS in STEM discipline (Chemistry/Biochemistry strongly preferred)
• GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering
• Demonstrated ability to function in a cross-functional team environment and to provide technical leadership
• Demonstrated ability to manage and prioritize competing priorities
• Strong written and verbal communications skills with various audiences
• Ability to influence diverse groups and manage relationships
• Willingness to relocate to contract manufacturing site or an estimated 3-year assignment before returning to designated Lilly site
Additional Preferences:
• Experience in quality support for Drug Substance manufacturing activities
• Thorough technical understanding of quality systems and regulatory requirements
• Knowledge of pharmaceutical manufacturing operations
• Demonstrated coaching and mentoring skills
• Experience in root cause analysis
• Demonstrated application of statistical skills
• Proficiency with computer system applications
Additional Information:
• Must complete required training for API EM Quality Assurance
• Some international travel (<25%) is required primarily to Indianapolis, Indiana
Some off-shift work (night/weekend) may be required to support 24/7 operations
