Representative Material Management Quality Assurance

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Job 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.

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).

Three plus years of experience in Quality

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

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 ( ) 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 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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