Associate, QA Compliance - QA QC

Role Summary

The Associate, QA Compliance – QA for QC provides QA oversight for the Quality Control Laboratory, guiding issues such as non-conformance investigations, change control proposals, procedure revisions, validations, commissioning and qualification activities. Supports floor QA Representatives and serves as CSQA/CSV subject matter expert for QC lab computer systems and equipment, ensuring GMP compliance and preparation support for regulatory inspections. The role involves leading QC Lab personnel on quality matters, coordinating with internal and external partners, and participating in continuous improvement initiatives.

• 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 quality standards compliance.
• Maintain a safe work environment by adhering to safety rules and supporting HSE goals.
• Lead, mentor, and coach QC Lab personnel on quality matters.
• Provide quality oversight for verification, validation, and lifecycle management of computer systems supporting QC Labs, including review of test cases and discrepancy resolution.
• Participate as an active member of the local Lab team, contributing to Lean Lab initiatives and continuous improvement.
• Assess and triage deviations/observations within the local QC Lab team.
• Collaborate with Lilly support groups and external partners to resolve QC Lab issues.
• Participate in self-led inspections and support internal/external regulatory inspections.
• Review and redline documents to ensure quality attributes are met (deviations/observations, procedures, technical studies, validation protocols, change controls, engineering documents).
• Participate in Six Sigma projects to improve productivity within the local process team or quality organization.
• Support project and process improvement initiatives for Lab Teams as a 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 of experience in the pharmaceutical or medical device industry in QA roles.
  • Previous QC Lab oversight experience.
  • Previous CSQA / CSV experience.
• Education:
  • Bachelor's degree in a science, engineering, computer, or pharmaceutical-related field 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 batch disposition, materials management, laboratory specifications and methods.
  • Equipment qualification and process validation experience.
  • Experience with SAP or other inventory management systems.
  • Experience with device and parenteral product materials.
  • CQA certification from ASQ.
  • Experience with deviation and change management systems including Trackwise.
  • Proficiency with GMP computer systems (Lab, CAPA, Document Control).
  • Strong oral and written communication and interpersonal skills; strong technical writing abilities.

• CSQA/CSV expertise
• GMP/compliance knowledge
• Laboratory information systems and document control proficiency
• Quality auditing and inspection support
• Strong analytical and problem-solving abilities

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

• Ability to work 8-hour days – Monday through Friday; may require support outside regular hours for continuous manufacturing operations.
• Willingness to carry a company cell phone for off-hour quality support to the lab.
• Travel up to 5% to Indianapolis, IN for meetings and coordination with global regulatory organizations.