Quality Assurance Specialist (Corporate Engineering)

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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 signature
• Perform site self-assessment
• Create deviations, change controls, action items, quality plan
• Ensure requirements are reflected in functional CE procedures
• Review 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 5 plus 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.

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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