Quality Assurance Specialist (Corporate Engineering)

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 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.

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