QA Principal Associate
4 weeks ago
We’re looking for people who are determined to make life better for people around the world.
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and systems to enable a successful startup into GMP manufacturing operations.
The API (Active Pharmaceutical Ingredient) Small Molecule Manufacturing Quality Assurance representative provides support to all quality activities at the Lebanon, Indiana facility. The QA representative position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated processes and are compliant to cGMPs and regulatory commitments.
Responsibilities:
Key Objectives/Deliverables:
Provide quality oversight of small molecule manufacturing operations with a focus on holistic review of key activities associated with or impacting the manufacturing processes. Serve as the initial point of contact for all quality-related issues. Coordinate and perform QA responsibilities of API manufacturing (small molecules). Review and approve documents including, but not limited to, procedures, master production records, change controls, deviations, equipment qualifications, analytical methods, process validations, and computerized system validations. Provide technical support for deviation investigations including root cause analysis, countermeasure development, and implementation of actions. Assess the impact of change controls and events on the product and regulatory commitments. Ensure all processes are in an appropriate state of control. Escalate quality issues to LP1 QA management. Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release. Provide and coordinate designated sections for Annual Reports and Annual Product Reviews. Establish and monitor KPIs such as Right First Time (RFT), investigation timeliness and batch release. Work with Lilly support groups to resolve product related issues. Identify opportunities for and participate in continuous improvement. Participate in regulatory inspection preparations with small molecule manufacturing operations. Participate on the Technical Review Board. Ensure inspection readiness through compliance auditing, site self-assessments, GMP education, monitoring, establishing and enhancing Quality systems. Complete other duties as assigned.
Basic Requirements:
Additional Skills/Preferences:
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
#WeAreLilly
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