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Organization Overview:

Drug Product External Manufacturing Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations, and termination.

The QA for QC Rep for Drug Product External Manufacturers (CMs) provides quality laboratory oversight, assistance, and initial guidance to issues such as non-conformance investigations, change control proposals, method transfer, specifications, validations, and other duties associated with daily CM lab activities. This role provides and assures compliance to established quality policies by resolving identified procedural gaps and works with JPTs to assure the CM maintains a state of control with regards to laboratories. The QA for QC Rep is integral for maintaining GMP compliance, providing support as applicable during preparations for pre-approval/general inspections by various agencies, and launching new products, processes, and CMs.

Key Objectives/Deliverables:

A specific focus for this role is Laboratory Primary Loop activities, which provides oversight, assistance, and guidance to CMs and other DPEM team members for lab activities.

• Participate in the review of local procedures related to Lilly quality standards and provide redlines to ensure quality attributes are met.

• Provide support to launch new products/ packages/ CMs.

• Support the operational control strategy.

• Provide technical leadership and project management oversight to drive improvements to CM lab quality systems.

• Provide oversight to the DPEM stability program, including protocols, studies, metrics, as well as routine review of the data.

• Build and maintain strong working relationships with CM key personnel.

• Support CMs effort to maintain and improve their quality systems, including consulting with CM labs to understand Lilly laboratory quality requirements.

• Provide initial consult guidance and quality oversight of manufacturing issues, deviations, change controls and counter measures.

• Be the change owner as appropriate for analytical method, specification, or stability protocol revisions.

• Partners with Joint Process Teams on CM lab processes; attend meetings as needed.

• Work with Lilly support groups to resolve product related issues.

• Provide support on site or remotely before, during and after GQAAC audits.

• Routinely have face-to-face communications with CMs.

• Execute SOP assessments of CMs and track completion of outstanding issues.

• Review/approve laboratory GMP documents, including testing methods, procedures, change controls, method transfer/validation protocols, analytical standards, stability data, and associated reports.

• Create/update Darwin/LIMS master data as required per change controls.

• Input/verify laboratory data into Darwin/LIMS.

• Provide guidance and quality oversight of laboratory issues, deviations, change controls and countermeasures.

• Coordinate the supply of reference standards to CM labs, as applicable.

• Support/oversee implementation of analytical method and specification and change request for labs supporting final product release testing.

• Support ongoing maintenance of analytical methods and specifications.

• Create Certificates of Analysis or other similar documentation for internal and external customers

• Participate in OOS investigations.

• Provide and coordinate designated sections including trend analysis of analytical data for Annual Reports and Annual Product Reviews.

• Advise DPEM QA Management and JPT on technical laboratory issues.

Basic Qualifications

• Education:

• Bachelor's Degree in a science related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences or equivalent experience.

• Experience:

• At least 3 years Pharmaceutical Quality Control Experience.

• Demonstrated relevant experience in a GMP facility's lab

Additional Skills/ Preferences

• Experience in electronic quality systems preferred (Darwin/LIMS, GPCMS, CAPA, SAP, Trackwise).

• Understanding of Micro/Sterility Testing.

• Knowledge regarding Specification and Materials/Supplier Management.

• Demonstrated knowledge regarding product stability and program oversight.

• Project management skills.

• Coaching and mentoring skills.

• Technical understanding of cGMPs and the Global Quality Standards.

• Knowledge of Pharmaceutical Manufacturing Operations.

• Strong written and verbal communication skills.

• Teamwork and interpersonal skills exhibited across functional areas.

• Ability to organize, prioritize, multi-task, and influence diverse groups.

• Strong decision making and problem-solving skills.

• Technical knowledge of laboratory quality systems, methods, and equipment.

Additional Information

• Shift is days, but off-hours may be necessary to support operations.

• Travel is possible, up to 30%.

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.

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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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