Senior Associate QA for QC at Eli Lilly and Company

Limerick, County Limerick, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

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

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

Skills

GMP

LIMS

Data Integrity

Deviations

Change Controls

Risk Assessments

Laboratory Investigations

Audits

Inspections

QA Oversight

QCL Laboratories

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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