Quality Assurance Specialist

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 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.

Job Description

QA for Corporate Engineering Quality Systems provides quality support and oversight to the corporate engineering quality system including Global Facilities Delivery, Engineering Technical Center, and some elements of Global Packaging and Robotics.  The QA person will work across the corporate engineering functions to implement requirements from applicable standards (e.g., EFS, GQS, LQS) and drive quality improvements where warranted.  The role will also own a Global Quality Standard in the 200 Series.

 

Job Responsibilities

Provide oversight for Corporate Engineering (CE) quality system execution.

Approve CE local procedures that impact quality and other CE documents that require quality signaturePerform site self-assessmentCreate deviations, change controls, action items, quality plan Ensure requirements are reflected in functional CE proceduresReview proposed changes to engineering and quality standards as needed

Review Best practices and master specs

Own and execute the supplier/ service provider quality management for corporate engineering

Perform computer system quality responsibilities for systems owned by corporate engineering

Provide Quality support to the Global Facilities Delivery (GFD) organization, including Quality oversight of the GFD operations and GFD projects

Partner with Engineering / Automation to interpret/ implement requirements.

Own a Global Quality Standard in the 200 series. This includes evaluating new and revisions to external environment and working with engineering SMEs to determine if internal changes are needed. It also includes being connected to the sites to understand site implementation.

Basic Qualifications

Bachelor's Degree in Engineering or equivalent.

Strong knowledge of CGMP and quality systems with a minimum of 10 years of direct CGMP experience.

Direct experience with at least one FUME quality systems (e.g., maintenance)

Additional Skills/ Preferences

Demonstrated ability to interpret and apply standards to different situations.

Demonstrated ability to communicate and deliver constructive feedback to customers, including good oral, written, and presentation skills.​

Ability to travel to training courses, conferences, association meetings, and sites.

Ability to share information with other members of the group and drive needed changes.

Computer system quality training and/or equivalent experience.

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.

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