Sr. Associate - QA (Floor Support)
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Upload Your ResumeAbout This Role
The Sr. Associate - QA (Floor Support) provides daily oversight, assistance, and guidance on various quality issues for the Chemical Dispensing team. This role ensures GMP compliance and supports regulatory inspections at Lilly.
Responsibilities
- Adhere to safety rules and maintain a safe work environment by supporting HSE corporate and site goals
- Lead, mentor, and coach operations and support personnel on quality matters
- Ensure regular presence in operational areas to monitor GMP programs and quality systems
- Assess and triage deviations / observations that occur within the local process team
- Work with Lilly support groups and external partners to resolve or provide advice on product related issues
- Participate in self-led inspections and provide support during internal / external regulatory inspections
- Effectively review and / or redline documents to ensure quality attributes are met
- Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization
- Support project and process improvement initiatives for Plant Process Teams as representative of the Quality function
- Approve commissioning qualification / validation documents for computer systems and equipment
Requirements
- Bachelor's Degree in a scientific field
- 3+ years of manufacturing experience
- At least 1 year supporting quality
Qualifications
- Bachelor's Degree in a scientific field
- 3+ years of manufacturing experience, at least 1 year supporting quality.
Nice to Have
- Floor support experience
- Proven ability to work independently or as part of a team to resolve an issue
- Strong attention to detail
- Experience in GMP production environments or QCL
- Previous experience with Deviation and Change Management processes
- Proficiency with computer systems including Microsoft Office products, Regulus, TrackWise, PMX, and SAP
- Strong oral and written communication and interpersonal skills
- Demonstrated decision making and problem-solving skills
- Demonstrate technical writing and communication skills
Skills
* Required skills
Benefits
About Lilly
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and delivering life-changing medicines, improving disease understanding, and giving back to communities through philanthropy and volunteerism.