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  • Emplois similaires à : Sr. Associate, QA Analytical (R2 - R3)
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Analytical QA Lead – GMP Compliance & Method ValidationEli Lilly and Company • Indianapolis, Indiana, United States
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Analytical QA Lead – GMP Compliance & Method Validation

Eli Lilly and Company
  • US
    Indianapolis, Indiana, United States
  • US
    Indianapolis, Indiana, United States
Postuler Maintenant

À propos

Organization and Position Overview 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. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development.
The Sr. Principal Associate for Analytical Quality Assurance ensures that laboratory activities conducted in the Lilly Medicine Foundry and with external partners comply with global and site quality standards and current Good Manufacturing Practice (cGMP). This role will provide quality oversight for the detailed design and quality processes related to GMP testing and analytical development, as well as qualification support for analytical methods and instrumentation. The position is responsible for ensuring that the quality management system is established and adhered to for this area.
Responsibilities
Provide quality oversight in analytical testing, including molecule and modality support, qualification of new contract labs, audit support, quality system ownership, leading compliance projects for analytical within the Foundry, and quality assessments of documentation (e.g., deviations, change records).
Provide quality oversight of method verification, qualification and validation activities.
Ensure that appropriate quality systems are in place and utilized, facilitate quality improvement initiatives, and implement new quality standards.
Evaluate potential impact of incidents on quality of materials or data integrity.
Conduct investigations for deviations, stability failures and out‑of‑specification (OOS) results, and review and approve the corresponding documentation.
Review and approve or reject GMP documentation, ensuring review by appropriate technical experts.
Be available for consultation on quality‑related issues as needed.
Network with Lilly quality organizations to implement quality laboratory systems and share best practices.
Promote a positive quality culture and oversee quality presence in laboratory areas.
Identify and lead process improvement projects impacting multiple business areas.
Basic Requirements
Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field with a minimum of 5 years technical laboratory experience; quality assurance experience in the pharmaceutical industry preferred.
Relevant industry experience in highly paced working environments and large‑scale capital project deliveries.
Strong knowledge of analytical method development and validation.
Strong knowledge of current GMP expectations and application of quality management systems.
Minimum 5 years of experience in laboratories and analytical testing.
Qualified applicants must be authorized to work in the United States on a full‑time basis.
Additional Preferences
Ability to manage in a dynamic environment and adjust to frequent change.
Ability to provide input and influence decision making for complex technical issues.
Proven experience identifying innovative processes and implementing them with a focus on quality and acceleration.
Experience with networking across industry groups or committees.
Success in coaching and mentorship.
Ability to establish key relationships and influence peers and business partners.
Strong communication skills.
Ability to identify and prioritize issues, develop, and implement solutions.
High learning agility and ability to deal with ambiguity and uncertainty; ability to design KPIs, metrics and data analysis.
Location
Initial location at Parkwood West, Carmel, Indiana.
Permanent location at the Lilly Medicines Foundry in Lebanon, Indiana.
EEO and Accommodations 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. Lilly is dedicated to helping individuals with disabilities actively engage in the workforce and offers accommodations. If you require accommodation to submit a resume, please complete the accommodation request form.
Compensation and Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 – $169,400. Full‑time employees may be eligible for a company bonus. Lilly offers a comprehensive benefit program, including eligibility to participate in a company‑sponsored 401(k), pension, vacation benefits, medical, dental, vision and prescription drug benefits, flexible benefits such as healthcare or dependent day‑care FSA, life insurance, death benefits, time‑off and leave of absence, and well‑being benefits (e.g., employee assistance program, fitness benefits, employee clubs and activities).
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  • Indianapolis, Indiana, United States

Compétences linguistiques

  • English
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