Authorized Quality Representative - Batch Disposition - Morning Shift
Location: Indianapolis, Indiana, United States
Category: Manufacturing/Quality
Job Type: Full Time, Regular
Job Id: R-77788
Organization Overview:
The mission of Quality Assurance is to provide independent oversight for manufacturing operations to ensure all products and materials meet quality requirements for their intended use and that quality systems are created, monitored, and maintained. The Authorized Quality Representative (AQR) in Indianapolis Parenteral Manufacturing (IPM) is responsible for final batch release of Semi-Finished products and supports plant quality leadership in managing key technical, quality, and compliance issues.
Responsibilities:
Perform final batch disposition of semi-finished drug product batches, including commercial and clinical trial materials, ensuring GMP compliance and timely release.
Provide guidance in operational areas to maintain robust Quality Systems and GMP compliance.
Review and approve GMP documents (deviations, procedures, protocols, specifications, change controls, complaints).
Participate in process improvement initiatives to enhance productivity within Batch Disposition and the site.
Maintain a regular presence in operational areas to monitor GMP programs and quality systems.
Lead, mentor, and coach site personnel on quality matters associated with Batch Disposition processes.
Provide technical leadership and direction on major deviations and investigations.
Communicate regularly with QA operations staff and process teams to resolve product-related issues.
Review Annual Product Reviews (APRs), ensuring data analysis quality and sound conclusions.
Participate in self-inspections and provide support during internal/external regulatory inspections.
Review and approve regulatory submission updates and changes to commercial product labeling.
Basic Requirements:
Bachelor’s Degree required in scientific disciplines such as Biochemistry, Microbiology, Analytical Chemistry, Pharmaceutical Science, Engineering, or equivalent work experience.
5+ years of experience supporting pharmaceutical manufacturing or quality, with expertise in parenteral pharmaceutical products.
Additional Skills/Preferences:
Strong critical thinking and independent decision-making skills.
Technical writing and communication proficiency to transfer knowledge across all organizational levels.
Ability to engage in crucial conversations while considering differing viewpoints respectfully.
Attention to detail and strong coaching skills.
Ability to influence diverse groups on complex regulatory, business, or technical issues.
Proficiency with systems such as Veeva, TrackWise, PMX, and SAP.
Strategic thinking with a balance of short-term and long-term business goals.
Additional Information:
Morning Shift: Tuesday to Saturday, starting at 6:00 AM, with possible off-shift support.
PPE required when entering manufacturing areas.
Position is tech ladder approved.
Equal Opportunity Employer:
Lilly is committed to diversity and inclusion. If you require accommodation during the application process, please complete the accommodation request form.
Compensation and Benefits:
Anticipated salary range: $96,000 - $178,200.
Eligible for company bonus, 401(k), pension, medical, dental, vision, and other flexible benefits.
Employee Resource Groups (ERGs):
Lilly offers strong support networks through ERGs such as PRIDE, Veterans Leadership Network, Women’s Network, and more.
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