Associate – QA Compliance for QC

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Position Description :

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, qualification and validation lifecycle 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 approver for QCL (Quality Control Labs) computer systems and equipment from initial system suitability through lifecycle management to ensure compliance with quality standards (GQS605 and LQS302).

Responsibilities include reviewing test cases, approving test execution deliverables, and approval of ongoing monitoring reports.

• 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.
• Ensure lab compliance to the Lilly Floor Time Program per Corporate Quality Practice CQP-101-4.
• Active member on local Lab team, as outlined in Manufacturing Standard of Excellence (MSOE), including participation with Lean Lab initiatives, daily huddle board, GEMBA walks, and continuous improvement.
• Ability to assess and triage deviations 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 site self-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).
• 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 needed

Requirements (Education, Experience, Training) :

• At least 4 years working in the pharmaceutical or medical device industry in QA roles.
• Previous QC Lab oversight experience.
• Previous CSQA / CSV experience
• Bachelor’s degree in science, engineering, computer, or pharmaceutical related field of study.

Preferred attributes but not required :

• 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.
• Previous experience with deviation and change management systems
• 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.

Additional Information :

• Ability to work 8-hour days Monday through Friday is required on site; up to 4 days per month (e.g. 1 day per week) may be WFH applicable.
• May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24 / 7) manufacturing operations.
• Ability to travel up to 5% to Indianapolis, IN for meetings and coordination with global regulatory organizations is required.

This job specification is intended to give a general overview of the job requirements when prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.

As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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.

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