Lilly
Healthcare
AnalyticalQASeniorAssociate(QAforQC)
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“Analytical QA Senior Associate (QA for QC) at Lilly. Skills: Quality Assurance, Laboratory operations, Digital systems, cGMP compliance. Act as primary QA representative for QCL laboratories. Provide independent oversight and leadership”
Industry & Context.
Problem-solving skills; Root cause analysis
What They're Looking For.
Must Have
Honours Degree in Microbiology, Biology, Chemistry, Pharmacy, Quality, Engineering, or related discipline, Minimum 3 years’ experience in Quality Assurance within biotechnology or pharmaceutical manufacturing, Experience with quality management systems, Proven expertise in deviations, change controls, risk assessments, laboratory investigations, root cause analysis and process improvement, QA floor presence for laboratories and supporting areas, Equipment qualification requirements, Knowledge of cGMP, FDAA regulations, Data Integrity, and Good Documentation Practices, Understanding of cross contamination requirements, Ability to work independently, Ability to work in a fast-paced, dynamic environment, Excellent organizational skills, Excellent problem-solving skills, Excellent communication skills, Excellent interpersonal skills
Nice to Have
Knowledge or experience in microbiology or virology or cell-based assays or bioanalytical processes, Knowledge or experience in biosafety assessments, Knowledge or experience in analytical method lifecycle management, Experience with LIMs, Experience with laboratory digital systems, Familiarity with QC laboratory operations, Familiarity with analytical testing
What You'll Do.
Act as primary QA representative for QCL laboratories
Provide independent oversight and leadership
Lead QA support for deviations
Lead QA support for change controls
Lead QA support for risk assessments
Lead QA support for laboratory investigations
Ensure timely and compliant resolution
Maintain time-on-the-floor presence
Monitor data integrity
Monitor adherence to GMP standards
Oversee digital systems
Map process data flow
Oversee equipment/system qualification
Review GMP documentation
Approve GMP documentation
Review sampling protocols
Approve sampling protocols
Review validation documents
Approve validation documents
Review analytical methods
Approve analytical methods
Drive process improvements across QC laboratories
Drive process improvements across digital workflows
Challenge QC operations
Challenge laboratory practices
Identify opportunities for improvement
Ensure adherence to Good Documentation Practices
Ensure adherence to Data Integrity principles
Support regulatory inspections
Ensure laboratory readiness
Ensure alignment with global standards
Foster a proactive quality culture
Foster a continuous improvement mindset
Support broader QA for QC function
Contribute to cross-functional quality initiatives
How You'll Work.
Team & Collaboration
Cross-functional quality initiatives
Communication Scope
Communication skills
Process & Methodology
Risk assessment, Process improvement
Full Job Description
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. **Analytical QA Senior Associate (QA for QC)** **Organization Overview:** Eli Lilly Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies. **Position Summary:** We are seeking a highly motivated and detail-oriented Analytical QA Sr. Associate, to join our Quality Assurance team supporting our QCL laboratories and ensure the highest standards of product quality and compliance. This role is ideal for a strong QA representative with experience in analytical laboratory oversight, capable of thriving in a fast-paced, startup-like environment. The successful candidate will provide QA oversight for laboratories and digital systems (e.g., LIMS, other e-systems), ensuring compliance, driving process improvements, supporting audits/inspections, and acting as a Business QA partner for lab e-systems. ### **Key Responsibilities** * Act as a primary QA representative for QCL laboratories, providing independent oversight and leadership. * Lead QA support for deviations, change controls, risk assessments, and laboratory investigations, ensuring timely and compliant resolution. * Maintain time-on-the-floor presence, monitoring compliance, data integrity, and adher
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