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Quality Assurance Batch Release Associate
3 months ago
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. We're looking for people who are determined to make life better for people around the world.Organization Overview:Drug Product External Manufacturing - US (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of North, Central and South American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.Responsibilities:The QA Associate for Batch Release is responsible for final disposition of manufactured and packaged drug product batches. This role ensures that all batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.Complete batch record and media fill reviews, reporting any issuesDetermine final disposition of batches by reviewing all required documentation including but not limited to change controls and deviationsOriginate and investigate deviations associated with batch recordsWork with Lilly support groups to resolve product related issuesParticipate in the creation and revision of standard operating procedures, Master Batch Records and Master Packaging OrdersCreate Certificates of Analysis or other similar documentation for internal and external customersReview and approve documentation that supports manufacturing (e.g., deviations, changes, procedures, protocols), as applicable.Assist in the establishment and revisions of Quality Agreements with affiliates and customers.Provide support to ensure on time completion of Annual Product ReviewsProvide support to launch new products/ packages/ contract manufacturers (CMs)Participate on Joint Process TeamsMaintain material management (e.g. check all API restrictions in SAP and apply those restrictions to finished product)Provide support for Notification to Management data gatheringProvide input for metrics reports to managementComplete process/productivity improvements and compliance projects as assignedOversee the batch release qualification process, benchmark with internal organizations, and implement improvementsContribute to Quality culture efforts at both DPEM and CMComplete other duties as assignedBasic Requirements:Bachelor's Degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences or related Life Sciences or equivalent experienceMinimum 3 years of experience in regulated manufacturing industry and/or quality experience; parenteral experience preferredAdditional Skills/Preferences:Proven ability to work independently or as part of a Team to problem solveExperience with Pharma industry electronic systems (SAP, Trackwise, Regulus)Previous experience with batch disposition for drug product manufacturing and packaging processesTechnical understanding of cGMPs and the Global Quality StandardsKnowledge of Pharmaceutical Manufacturing OperationsStrong written and verbal communication skillsTeamwork and interpersonal skills exhibited across functional areasAbility to organize, prioritize, multi-task, and influence diverse groupsStrong decision making and problem-solving skillsAdditional Information:Shift is days, but off-hours may be necessary to support operationsTravel is possible, up to 10%This position is an onsite position that requires you to be onsite the majority of the time. This is not a remote position. Position is based out of Indianapolis, IN at Lilly Corporate Center.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.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.#WeAreLilly
