- Provide QA oversight for PR&D, PRD CMOs and PRD GMP Service Providers as required. Ensure that appropriate Quality Systems are in place and are being utilized.
- Facilitate quality improvement initiatives, and the implementation of new quality standards. When necessary, evaluate potential impact of incidents on the product quality of materials, or the integrity of data.
- Ensure appropriate investigations are conducted for deviations, stability failures and out of specification (OOS) results. Review and approval of the corresponding documentation. When necessary, notify management of quality issues.
- Report and escalate decisions to the appropriate level. Perform Quality Assurance review and/or approval /rejection of GMP documentation and ensure that review/approval by appropriate technical experts has occurred.
- Be available for consultation on quality-related issues as needed.
- Provide quality oversight to ensure compliance with internal standards and applicable regulations by maintaining a regular presence in PRD areas and performing internal audits as scheduled.
- Monitor effectiveness of implemented corrective actions and improvement initiatives.
- Monitor trends in metrics of key quality systems (e.g. Deviations) to identify opportunities for continuous improvement.
- Provide Analytical QA oversight for executed activities for assigned molecules, including but not limited to method verifications, qualifications, validations, stability protocols, and technical reports.
- Provide support to the Reference Standard area as required. Basic Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or Engineering, or equivalent experience.
- Minimum 2 years of quality experience (pharmaceutical experience preferred) Additional Skills/Preferences
- Experience in Quality Assurance/Control, Technical Services, Laboratory, Development, or Manufacturing desirable. Additional Info:
- This position is based in Indianapolis, IN and requires onsite presence the majority of the time (not remote).
- Business title may vary depending on leveling. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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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Sr Associate - Indianapolis, United States - Eli Lilly and Company
Description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Main Purpose and Objectives of Position:
The Product Research and Development (PRD) Quality Assurance Associate Consultant Analytical Representative ensures continued organizational alignment with the business strategy and that laboratory activities conducted by PRD and CMOs are carried out in accordance with PRD quality standards and/or are in compliance with current Good Manufacturing Practice (cGMP). This role is responsible for assuring the laboratory maintains a state of control with regards to the generation and reporting of analytical data. Internal inspections and auditing of PRD laboratories will be supported and performed by this position
Key Responsibilities:
