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.

Lilly employees embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world.

Position Brand Description:

Independently works within the Lilly Branchburg Process Team environment per Manufacturing Standards for Operational Excellence (MSOE), resolves key technical/quality problems and drives solutions that impact the site. Leads small/medium-scale projects or programs with small/moderate risk and/or complexity. Provides assistance to cross-functional groups and/or management with troubleshooting investigations and problem resolution. Assists with implementation of quality improvement plans. Provides QA presence in areas of responsibility (materials management, warehouse etc.) by conducting periodic walkthroughs. Ensures regulatory compliance and procedural consistency between manufacturing facilities. Prepares cross-functional partners for Regulatory Inspections. Provides assistance, where necessary, during regulatory/partner inspections. Ensures compliance deviations associated with Lilly Branchburg Manufacturing Facilities are adequately addressed and completed on schedule.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

Evaluate deviations and ensure appropriate root cause/likely assignable cause(s) and assess quality impact. Recommend CAPAs and ensure CAPAs implemented are effective. Review and approve respective development and validation documentation. Evaluate change controls and associated risk assessments. Perform training within group or throughout organization as needed. Write/escalate Notifications to Management, as applicable. Ensure timely completion of all quality plan objectives and milestones. Support the on-time performance metrics. Assist in creating quality metrics. Keep Quality management informed of compliance issues. Perform periodic walk-throughs of supported facilities. Assist in activities associated with technology transfers to and from Lilly Branchburg facilities, as applicable. Attend and serve as a key resource in ad-hoc meetings to provide compliance guidance to material management and supplier quality issues. Support lot release through ensuring timeliness resolve of compliance issues, as applicable. Ensure compliance with applicable regulatory guidelines and GxP computer systems to global electronic records/signatures regulations (21 CFR Part 11, Annex 11, etc. as applicable); Perform review of regulatory submissions as necessary. Perform the compliance and risk evaluation of respective systems and departments. Participate in audits performed by partners, Lilly corporate, and/or regulatory agencies, as applicable. Identify and lead process improvement projects that impact systems used in a specific functional area. Serve as core member on Process Team(s), a cross functional group charged with making medicine, continuous improvement, and site support in accordance with Manufacturing Standards of Operational Excellence. Serve as key Quality liaison between disposition and compliance by supporting batch release through ensuring timeliness resolve of compliance issues as applicable. Perform and/or support Audit Trail Reviews (Data/System) as applicable.

Additional Responsibilities - Supplier Quality Assurance:

Manage creation, revision, and obsoletion of material specifications for incoming materials. Creation, revision, and obsoletion of material management related Standard Operating Procedures (SOP). Assess the investigation and evaluation of sourced material related incidents and/or deviations. Perform new raw material qualification activities. Must have a thorough understanding of SAP inventory management including quality management related activities. Perform material and supplier risk assessments, periodic performance reviews, assessments of supplier change notifications, material certifications, and issuance and review of supplier complaints. Manage quality agreements with suppliers of raw materials and GMP consumables. Must be willing to travel domestically and internationally to support audits of software vendors or vendors that provide computer related services to the site. Perform System Audit Trail Reviews.

Basic Requirements:

• BA/BS degree in the sciences with 3+ years of experience in the Biopharmaceutical industry.

• Previous technical experience should be in materials management and/or supplier quality activities associated with biotechnology manufacturing processes (large scale cell culture and purification processes).

Additional Preferences:

• Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable.

• Must have experience in developing, reviewing and/or approving the following types of development/validation documents: Validation Plans, User/Functional Requirement Specifications, IQ/OQ/PQ Protocol and Reports, Requirements Traceability Matrix, and Validation Summary Reports.

• Must possess a conceptual understanding of all Quality functions and business areas.

• Must possess depth and/or breadth of expertise within area of responsibility. Must have the ability to function in a fast-paced environment and communicate effectively with management.

• Must be able to work in a cross-functional environment.

• Must have demonstrate ability to work independently.

• Must be proficient in Microsoft applications.

Other Information:

• Shift work may apply.

• Travel required, approximately 5%.

• Lifting not required.

• Required to be on call.

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 ( LillyRecruitingCompliance@lists.lilly.com ) 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.

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