Associate, QA Compliance - QA for QC

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.

Organization Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism

Position Brand Description:

Lilly is a fortune 500 company in operation for over 140 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do. 

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. 

The QA Representative for the Quality Control Laboratory serves as Quality oversight to provide daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure revisions, validations, commissioning, and qualification activities. Advise and provide support for other floor support QA Representatives. The QA 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:

• Support the QA Compliance team and site in the execution of the site business plan and priorities for the QC Laboratory.
• Support as CSQA/CSV SME and approve commissioning/qualification /validation documents for QC Lab computer systems and equipment to ensure compliance with quality standards.
• 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 QC Lab personnel on quality matters.
• Provide quality oversight for the verification and validation, and lifecycle management of computer systems supporting QC Labs, including review of test cases, test execution, discrepancy resolution, etc.
• Active member on local Lab team, as outlined in MSOE standard, including participation with Lean Lab initiatives, daily huddle board and continuous improvement.
• Ability to assess and triage deviations / observations that occur within the local QC Lab team.
• Work with Lilly support groups and external partners to resolve or provide advice on QC Lab related issues.
• Participate in self-led inspections and provide support during internal/external regulatory inspections.
• Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents).
• Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization.
• Support project and process improvement initiatives for Lab Teams as representative of the Quality function.
• Network with Global Parenteral and Device Network sites as resources and benchmarking sources as applicable.

Minimum Requirements:

• At least 3 years working in the pharmaceutical or medical device industry in QA roles.
• Previous QC Lab oversight experience. 
• Previous CSQA / CSV experience

Education Requirements:

• Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.

Additional Preferences:

• Previous QC Lab experience.
• Experience with LIMS, LES, SAP, Veeva Q Docs, Darwin.
• Six Sigma Green Belt or Lean Training/Experience.
• Knowledge of operations business processes, such as batch disposition, materials management, laboratory specifications and methods.
• Previous equipment qualification and process validation experience.
• Previous experience with SAP or other inventory management systems.
• Previous experience with device and parenteral product materials.
• CQA certification from the American Society for Quality (ASQ)
• Previous experience with deviation and change management systems including Trackwise
• Proficiency with GMP computer systems including Lab systems, CAPA systems, and Document Control systems.
• Demonstrated strong oral and written communication and interpersonal interaction skills
• Demonstrated strong technical writing skills.

Other Information:

• Ability to work 8 hour days – Monday through Friday is required
• May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations. Must be willing to carry a company cell phone to field off hour quality support to the lab.
• Ability to travel up to 5% to Indianapolis, IN for meetings and coordination with global regulatory organizations is required.

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$65,250 - $169,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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