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 adherence to GMP standards.
- Oversee digital systems and LIMS, including process data flow mapping, equipment/system qualification, and audit trails.
- Review and approve GMP documentation, procedures, sampling protocols, validation documents, and analytical methods.
- Drive process improvements across QC laboratories and digital workflows to enhance compliance, efficiency, and quality.
- Challenge QC operations and laboratory practices from a QA perspective, identifying risks, gaps, and opportunities for improvement.
- Ensure adherence to Good Documentation Practices and Data Integrity principles across all activities.
- Support regulatory inspections and audits, ensuring laboratory readiness and alignment with global standards.
- Mentor and coach colleagues, fostering a proactive quality culture and continuous improvement mindset.
- Support the broader QA for QC function as needed, contributing to cross-functional quality initiatives.
Mandatory Requirements
Honours Degree (BSc, MSc, or PhD) 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 (e.g., TrackWise, OneQMS).
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.
Strong knowledge of cGMP, FDA/EMA regulations, Data Integrity, and Good Documentation Practices.
Understanding of cross contamination requirements.
Ability to work independently and in a fast-paced, dynamic environment.
Excellent organizational, problem-solving, communication, and interpersonal skills.
Preferred Qualifications
- Knowledge or experience in microbiology or virology or cell-based assays or bioanalytical processes, biosafety assessments, and analytical method lifecycle management.
- Experience with LIMs (e.g. Labvantage, MODA) and other laboratory digital systems.
- Familiarity with QC laboratory operations and analytical testing.
What We Offer
- Opportunity to be part of a state-of-the-art biotech startup facility with global impact.
- A collaborative culture that values quality, innovation, and continuous improvement.
- Career growth opportunities within one of the world’s leading pharmaceutical companies.
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 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.
#WeAreLillyUKandIreland