Quality Assurance

2 weeks ago

Indianapolis, United States Eli Lilly and Company Full time

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.

The QA for QCL (Quality Control Laboratories) Representative provides daily oversight, assistance, and guidance to issues such as analytical investigations, deviations, change control proposals, procedure / master formula revisions, validations, commissioning, and qualification activities.  The QA for QCL position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies. 

Responsibilities:

Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goalsLead, mentor, and coach QCL on quality mattersEnsure regular presence in laboratories to monitor GMP programs and quality systemsActive member of the lab areas they support through day-to-day presence and participation with project workApprove test plans and analytical investigationsAssess and triage deviations that occur as well as approve minor deviationsWork cross functionally with QCL, Equipment team, and Manufacturing to resolve issues while adhering to quality and documentation requirementsParticipate in self-led inspections and provide support during internal / external regulatory inspectionsAbility to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations, procedures, technical studies, validation protocols, change controls, and engineering documents)Participate in Lean Projects to help improve productivity within the local areaSupport project and process improvement initiatives for QCL as a representative of the Quality FunctionApprove commissioning qualification / validation documents for computer systems and equipment to ensure compliance with quality standardsNetwork with Global Parenteral Network sites as resources and benchmarking sources, as applicable flexibility within job assignmentParticipate in the investigation of analytical investigations or deviations, write / review change controls, and investigate deviations as required.

Basic Qualifications:

Bachelor’s or equivalent (Science or Engineering related degree preferred).Demonstrated equivalent experience in a GMP facility.

Additional Preferences:

Demonstrate strong oral and written communication and interpersonal skillsDemonstrated risk based decision making and problem solving skillsDemonstrate knowledge and understanding of manufacturing processes and Quality SystemsDemonstrate technical writing and communication skills.Proven ability to work independently or as part of a team to resolve an issueStrong attention to detailExperience in GMP production environments or QCL is desirablePrevious experience with Lilly Event and Change Management processesProficiency with computer systems including Microsoft Office products, Veeva, TrackWise, Darwin, SmartLab® and/or MODA.

Other Information:

May be required to respond to operational issues outside of core business hours / days.Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

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

  • Quality Assurance Manager

    1 day ago

    Indianapolis, United States Hansen Agri-PLACEMENT Full time

    PLEASE NOTE: We will not be able to reply to you if your resume does not meet the position requirements. There is NO closing date. This position will remain open until a suitable candidate is found.QUALIFICATIONS:- Education Four-year bachelors degree in food science, microbiology, etc.- Minimum 2-3 years of food manufacturing experience- Certified SQF is...

  • Quality Assurance Supervisor

    4 days ago

    Indianapolis, United States Morales Group Staffing Full time

    Position Summary: This position is responsible for routine segments of the quality assurance functions either directly or through QA Technicians. Responsible for the training of techniques and procedures for inspecting and testing customers products and for the conducting of research on products defects in order to recommend modifications in products and/or...

  • Quality Assurance Supervisor

    2 days ago

    Indianapolis, United States Morales Group Staffing Full time

    Position Summary: This position is responsible for routine segments of the quality assurance functions either directly or through QA Technicians. Responsible for the training of techniques and procedures for inspecting and testing customers products and for the conducting of research on products defects in order to recommend modifications in products and/or...

  • Quality Assurance Specialist

    3 days ago

    Indianapolis, United States RayzeBio Full time

    BackgroundRayzeBio is a dynamic biotechnology company headquartered in San Diego, CA with development and GMP operations in Indianapolis, IN. Having raised over $250M since company launch in late 2020, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs...

  • Quality Assurance Specialist

    2 days ago

    Indianapolis, United States RayzeBio Full time

    BackgroundRayzeBio is a dynamic biotechnology company headquartered in San Diego, CA with development and GMP operations in Indianapolis, IN. Having raised over $250M since company launch in late 2020, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs...

  • Director, Quality and Assurance

    1 day ago

    Indianapolis, United States Doxim Full time

    Doxim is the customer communications and engagement technology leader serving financial and regulated industries. Our platform with its suite of integrated, SaaS software and document technology solutions helps clients digitize operations, improve efficiency, and modernize customer experience. With Doxim, clients can communicate reliably and effectively,...

  • Director, Quality and Assurance

    2 days ago

    Indianapolis, United States Doxim Full time

    Doxim is the customer communications and engagement technology leader serving financial and regulated industries. Our platform with its suite of integrated, SaaS software and document technology solutions helps clients digitize operations, improve efficiency, and modernize customer experience. With Doxim, clients can communicate reliably and effectively,...

  • Director, Quality and Assurance

    4 days ago

    Indianapolis, United States Doxim Full time

    Job DescriptionJob DescriptionDoxim is the customer communications and engagement technology leader serving financial and regulated industries. Our platform with its suite of integrated, SaaS software and document technology solutions helps clients digitize operations, improve efficiency, and modernize customer experience. With Doxim, clients can communicate...

  • Quality Assurance Associate

    3 weeks ago

    Indianapolis, United States Integrated Resources, Inc Full time

    Job Title: Quality Assurance Associate Location: Indianapolis, IN Duration: 03 Months Description/Comment: The individuals will work on our 1st shift team in support of our Material Review Board (MRB) team and processes. In this role, they will review previously written Non-Conformances, (Company), looking for key defined aspects, and adding...

  • Quality Assurance Associate

    4 days ago

    Indianapolis, United States Integrated Resources Full time

    Job Title: Quality Assurance Associate Job Location: Indianapolis, IN (100% on-site) Duration: 3 months Job Description: · The individuals will work on our 1st shift team in support of our Material Review Board (MRB) team and processes. In this role, they will review previously written Non-Conformances, (Company), looking for key defined...

  • Quality Assurance Associate

    1 week ago

    Indianapolis, United States Integrated Resources, Inc Full time

    Job Title: Quality Assurance Associate Job Location: Indianapolis, IN (100% on-site) Duration: 3 months Job Description: · The individuals will work on our 1st shift team in support of our Material Review Board (MRB) team and processes. In this role, they will review previously written Non-Conformances, (Company),...

  • Quality Assurance Associate

    3 weeks ago

    Indianapolis, United States Integrated Resources, Inc Full time

    Job Title: Quality Assurance Associate Job Location: Indianapolis, IN (100% on-site) Duration: 3 months Job Description: · The individuals will work on our 1st shift team in support of our Material Review Board (MRB) team and processes. In this role, they will review previously written Non-Conformances, (Company),...

  • Quality Assurance Manager

    6 days ago

    Indianapolis, United States EHOB, Inc Full time

    PurposeThe Quality Assurance Manager provides direction and leadership to the quality group including people management as follows: managing performance; addressing disciplinary issues; hiring; assisting people with career development; and communicating information to direct reports and management. They are required to ensure the team is aligned with and...

  • Quality Assurance Manager

    6 days ago

    Indianapolis, United States EHOB, Inc Full time

    PurposeThe Quality Assurance Manager provides direction and leadership to the quality group including people management as follows: managing performance; addressing disciplinary issues; hiring; assisting people with career development; and communicating information to direct reports and management. They are required to ensure the team is aligned with and...

  • Consultant-Quality Assurance

    2 weeks ago

    Indianapolis, United States CareerBuilder Full time

    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...

  • Consultant-Quality Assurance

    3 weeks ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...

  • Consultant-Quality Assurance

    3 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Sr. Quality Assurance Manager

    7 days ago

    Indianapolis, United States BuildSubmarines.com Full time

    Description SUMMARY: Develop and maintain an effective Quality Assurance Program to ensure proper compliance with government contractual requirements, aircraft maintenance requirements, practices, and procedures with emphasis on compliance with Ground and Flight Operations Procedures and the Repair Station Quality Manual. ESSENTIAL DUTIES AND...

  • Sr. Quality Assurance Manager

    2 weeks ago

    Indianapolis, United States AAR Full time

    Description SUMMARY:Develop and maintain an effective Quality Assurance Program to ensure proper compliance with government contractual requirements, aircraft maintenance requirements, practices, and procedures with emphasis on compliance with Ground and Flight Operations Procedures and the Repair Station Quality Manual.ESSENTIAL DUTIES AND RESPONSIBILITIES:...

  • Consultant-Quality Assurance

    6 days ago

    Indianapolis, United States Eli Lilly Full time

    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...