Quality Assurance Representative - Device Assembly and Packaging - BioSpace : Job Details

Job DetailsAt 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 Quality Assurance Representative for the Device Assembly & Packaging team provides daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedures revisions, validations, batch disposition, commissioning, and qualification activities. The Quality Assurance Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval/General Inspections by various regulatory agencies.Key Objectives/Deliverables:

• Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.
• Lead, mentor, and coach operations and support personnel on quality matters.
• Ensure regular presence in device assembly and packaging areas to monitor GMP programs, and quality systems.
• Active on local process teams or indirect participation through project support activities.
• Ability to assess and triage deviations that occur within the device assembly and packaging areas.
• Work with Lilly support groups and external partners to resolve or provide advice on product related issues.
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Effectively review and / or redline to ensure quality attributes are met. (i.e., deviations, procedures, technical studies, change controls)

• Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization.
• Support project and process improvement initiatives for Plant Process Teams as representative of the Quality function.
• Approve commissioning qualification / validation documents for computer systems and equipment to ensure compliance with quality standards.

Minimum Requirements:

• Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.
• Minimum of 4 years experience in GMP facility.

Additional Preferences:

• Previous work with combination products or devices with experience with US/EU regulations and notified bodies.
• CQE, or CQA certification from the American Society for Quality (ASQ)
• CSQA experience
• Previous experience in GMP production environments.
• Previous facility or area start up experience.
• Demonstrate strong oral and written communication and interpersonal skills.
• Demonstrated decision making and problem-solving skills.
• Demonstrate knowledge and understanding of manufacturing process and Quality Systems.
• Proficiency with computer systems including Microsoft office products, SAP, Trackwise, etc.
• Strong attention to detail
• Proven ability to work independently or as part of a team to resolve issues.
• Ability to work 8 hour days - Monday through Friday.
• Ability to work overtime as required.
• Ability to travel up to 10% for meetings and coordination with global regulatory organizations.

Other Information:

• May be required to respond to operational issues outside of core business hours / days.
• Applicant may work in various areas within the device assembly and packaging (DAP) buildings. Mobility requirements should be considered when applying for this position.

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 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