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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 global 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 Material Management Quality Assurance (MMQA) Representative has the responsibility for providing quality oversight for Qualification of Purchased Material in Product Research and Development (PR&D) Clinical Trial activities.  This includes responsibility for the approval of specifications, batch release of raw materials, excipients, and packaging components.  The MMQA Representative is also responsible for ensuring all material suppliers and vendors have been adequately qualified and drive continuous improvement in the Materials Quality System across PR&D.

Scope:            

Purchased Material (raw materials, excipients, GMP consumables and packaging components) in Product Research and Development (PR&D) Clinical Trial activities

Key Responsibilities:

• Ensure cGMP Compliance and maintain and improve Quality Systems.

• Maintain adequate document control for raw materials, excipients, GMP consumables and packaging components.  Review and coordinate, or participate, in local procedure creation, revision, and changes as a SME (subject matter expert).  Write and revise procedures and training as required.

• Maintain a constant state of inspection readiness by providing the necessary support and participating in internal/external audits, SSI and SSA.

• Provide Quality support and oversight for Purchased Material release process, including document review, Usage Decision, material qualification, managing inventory status and re-evaluation.

• Issue GMP certificates such as TSE Certificate and Release memos.

• Work with business partners to ensure timely release of raw materials, excipients, GMP consumables and packaging components to support business needs. 

• Review and approve GMP documents such as specification, change control, investigations/deviation and supplier complaint records. 

• Ensure all suppliers of purchased materials (raw materials, excipients, GMP consumables and packaging components) for use in GMP operations are appropriately and timely qualified and approved.

• Maintain Supplier/CP qualification status activities such as supporting supplier/CP audit program, drafting, review and approval of quality agreements and associated documents. Evaluate supplier notification and vendor/CP changes to ensure compliance and adequate support to meet business needs.

• Perform other related duties as assigned.

Basic Qualifications:                        

Bachelor’s degree in applicable Life Sciences (Examples: Pharmacy, Chemistry, Engineering).

Additional Skills/Preferences:       

Materials Science degree preferred

Knowledge of corporate policies and procedures, SOPs, and cGMPs; GQS and regulatory requirements, knowledge of and user-skills related to TrackWise, Quality Doc., and SAP; basic computer skills; and soft skills including communication, interpersonal interactions, technical writing, organizing, project management, prioritizing, observation, evaluation, strong problem-solving and decision making.

Previous Quality Assurance Experience including batch release and supplier qualification.

Previous pharmaceutical manufacturing experience.

Experience with providing Quality oversight for Collaboration Partners

Experience with packaging components

Experience with Material Movement Logistics

This role is required to be onsite a minimum of 3 days per week at our Lilly Tech Center North

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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