Join American pharmaceutical leader Eli Lilly and Company, currently hiring Quality Assurance Batch Disposition / Flow Mentor in Indianapolis, Apply Lilly careers in Indianapolis Indiana.
Position : Quality Assurance Batch Disposition / Flow Mentor
Location : Indianapolis, Indiana
Job id: R-33428
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 35,000 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.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 Quality Assurance – Authorized Quality Representative (AQR)/Flow Mentor supports and assists the Plant Quality Leader in managing key technical, quality, and compliance issues while also responsible for final disposition of Semi-Finished drug products. They provide guidance, coaching and advice to the plant flow teams (cross-functional) on quality and compliance matters and mentor the operations quality organization to continue to develop capabilities related to quality assurance and compliance as well as parenteral manufacturing. They provide guidance to the site for Batch related issues, such as non-conformance investigations, issue resolution, and other batch disposition activities. Additionally, they serve as a technical leader within Quality to ensure proper adherence to Global and Local Quality requirements and ensure that there are adequate quality systems in place related to the Batch Disposition process to ensure product released to the market meets applicable GMP standards.
Responsibilities:Technical leadership – Quality and GMP Compliance:Understand the technical and compliance aspects of manufacturing parenteral drug product, including the interaction of the chemistry, sterility assurance and equipmentProvide technical leadership to key quality matters. Provide direction and coaching regarding major and/or significant deviations and investigationsEnsure regular presence in operational areas to monitor GMP programs and quality systemsBe responsible and influential with respect to implementation of regulatory guidance, technology advancements, broader external trends and understanding of how changes could impact Eli Lilly.Author, review, or approve documents, including personnel qualification strategies for quality staff, control strategies, investigations, change controls, validations, qualifications, procedures, technical studies, etc. to ensure quality attributes are met and compliance with quality standards.Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.Batch Disposition:Performs final batch disposition of semi-finished drug product including commercial and clinical trial materials to ensure high quality medicine (GMP Compliance) is released to market in a timely manner.Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: Non-conformances, procedures, protocols, specifications, and change controls).Participates in Six Sigma project or process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.Coaching/Mentoring:Coach and mentor quality operations and other functions supporting parenteral manufacturing operations in topics related to quality and GMP compliance, operational excellence, technical documentation, issue resolution, and process monitoring.Provide regular communication with QA operations staff and Process Teams to resolve issues or provide advice on product related issues.Coach individuals on inspection interactions, and in preparation of specific topics for inspection readinessInspection readiness:Participate in site inspection readiness program and site self-inspection programs and provide support during internal / external regulatory inspectionsLeads preparation of key quality and compliance topics for audit and inspection readinessParticipate in regulatory inspections and internal audits and assist with responses to these inspections and audits.Cross-functional, network and customer interactions:Work within cross-functional teams in a positive fashion to implement quality objectives and deliver on business plan and site objectives.Interface with the quality network (e.g., Global Parenteral Network Sites) to benchmark practices and harmonize approaches in quality matters supporting manufacturing operations.Interact with regulators, or other outside stakeholders on quality/compliance issues or in support of internal and external agency audits.Assist Plant Quality Leader:Assist and advise the Plant Quality Leader in major technical and compliance issues, non-conformities, complaint investigation and deviation investigation, including communication and escalation, documentation write-up and review, etc.Participate in Plant Governance forums for topics related to Quality and GMP compliance: Assist the Plant Quality Leader in leading and coordinating the Plant Quality Lead TeamAct as the primary back-up for the Plant Quality Leader in their absence upon delegation of authority
Basic Requirements:Minimum of Bachelor’s Degree required in scientific disciplines of Biochemistry, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, Microbiology, Analytical Chemistry, or Engineering (or equivalent work experience). Demonstrated relevant experience in a GMP facility.Proficiency with computer systems including Microsoft Office products.Ability to work independently and with minimal supervision.Technical writing and communication skills are used daily and the ability to effectively communicate and transfer knowledge to all levels of the organization is essential. Attention to detailCoaching skills
Additional Skills/Preferences:Preferred 10 years’ experience directly supporting pharmaceutical manufacturing or quality, with experience in parenteral pharmaceutical products.Although not a supervisory role, technical leadership capabilities, and the ability to train/coach others.Ability to influence and communicate to diverse groups on complex regulatory, business, or technical issues within the site and function.Proficiency in delivering highly complex tasks and / or tasks that are highly cross-functional.Strategic thinking and ability to balance short term needs with long term business evolution.Proficiency with local computer systems including Veeva, TrackWise, PMX, Darwin, and SAP
Additional Information:Day Shift, possible off-shift support.This position will be in Indianapolis, but could require some travel, less than 10%, including international.Tasks require entering manufacturing areas which require wearing appropriate PPE.This position is tech ladder approved.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 ( Lilly_Recruiting_Compliance@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.
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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
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