QA Scientist - Quality Operations
: Job Details :

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. Were looking for people who are determined to make life better for people around the world.

Company Overview:

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our worlds greatest health challenges.

This role is at the CORE Indianapolis facility, formerly Point Biopharma. The Center of Radioligand Excellence (CORE) is responsible for the Commercial launch of RLTs, supply of late-stage investigational products, and scale-up/optimization for Ph3 and commercial launches.

Position Overview:

The Scientist - QA team member provides daily QA on the floor oversight, assistance, and guidance to records such as deviations, non-conformance investigations, change controls, procedures, master batch record reviews, technical protocols/reports, validations, batch disposition, commissioning, and qualification activities.Advise and provide floor support.This position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.

Responsibilities:

• Ensure regular presence in operational areas (preparation, formulation, synthesis, filling and visual inspection, AQL, QC, warehouse etc. areas) as a part of QA on the Floor program to make sure facility is compliant with GMP and regulatory standards and inspection ready.
• Participate in facility QA on the Floor walkthrough, identifying gaps and resolving with the area owner promptly. Escalate any critical issues to the QA Management in a timely manner.
• Review related batch records (inclusive of third-party batch review), analytical data, sterility data and shipment data associated with parenteral manufacture, and final packaged product.
• Ability to effectively review and / or redline GMP documents to ensure quality attributes are met (i.e., deviations / observations, procedures, specifications, technical studies, validation protocols, change controls, CAPA, engineering documents, etc.).
• Participate in internal audits and/or provide support during internal/external regulatory inspections.
• Ability to assess and triage deviations / observations that occur within the local process team.
• Lead, mentor, and coach operations and support personnel on quality matters.
• Effectively communicate with Associate Director - QA and other Quality Representatives on quality and operational issues.
• Participates in Six Sigma projects or process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Work cross functionally and collaboratively with all levels of the organization.
• Foster positive demeanor, culture and professional attributes in alignment with Lilly CORE values.
• Perform any additional duties as required to support the business.

Accountabilities:

• Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
• Provide technical and quality review and approval of project documents to ensure compliance with Lilly CORE Quality Standards as well as project and local quality procedures
• Work with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross-functional support with focus on the Manufacturing areas.
• Support the organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring and training of new Quality and other project staff.
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
• Support the execution of inspection readiness activities including support of site self- inspections.
• Lead project initiatives needed in support of the project and Quality function.
• Resolve or escalate any compliance issues to the project, site, and Quality Management.
• Provides guidance for deviations, observation handling; change control proposals; document creation and revisions.

Basic Requirements:

• Bachelor's degree in a STEM field
• 3+ years working in the pharmaceutical manufacturing industry, preferably in Quality Assurance roles

Additional Preferences:

• Excellent oral and written communication skills
• Demonstrated risk-based decision making and problem-solving skills
• Demonstrate knowledge and understanding of manufacturing processes and Quality Systems
• Proven ability to work independently or as part of a team to resolve an issue.
• Operate and execute with an extreme sense of urgency.
• Strong attention to detail.
• Excellent organizational and interpersonal skills.
• Demonstrated ability to manage multiple projects, set priorities, and work in a fast-paced environment under tight timelines.
• Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel and QMS systems such as Trackwise, Veva Vault.

Additional Information:

• Ability to work 8-12 hour shifts onsite (not eligible for remote work).
• Ability to work overtime, weekends, or different shifts as required
• May be required to respond to operational issues outside of core business hours / days.
• Will work in various areas within the radiopharmaceutical plant following safety guidelines.Gowning and dosimetry requirements apply. Potential exposure to radiation should be considered.

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 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), Womens Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$63,000 - $162,800

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 Lillys compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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