Senior Associate, Quality Assurance - QA for QC

100 Eli Lilly and Company; Wisconsin; Vor Ort; USD 66.000 - 172.000; Vollzeit

Zusammenfassung

Lilly in Kenosha County, Wisconsin seeks a Senior Associate, Quality Assurance – QA for QC to provide quality oversight across QC labs, supporting deviations, change controls, validations, and inspections to ensure GMP compliance.

The role includes reviewing instrument commissioning, leading safety initiatives, mentoring lab staff, and collaborating with global QA networks to share best practices, with on-site presence required.

Qualifikationen

• Bachelor’s degree in science, engineering, or pharma, or equivalent experience.
• Minimum 5 years in pharma QC with GMP exposure.
• On-site presence required.
• Experience with LIMS, SAP, Veeva QMS and electronic systems.

Aufgaben

• Provide quality oversight in QC labs, including deviations and investigations.
• Review method transfers, verifications, validations and computer system deliverables.
• Support change controls, commissioning/qualification activities and regulatory readiness.
• Lead and mentor QC laboratory personnel on quality matters.
• Participate in inspections and continuous improvement initiatives.

Kenntnisse

Quality Assurance

GMP Compliance

Lab QC Experience

Deviation Handling

Regulatory Knowledge

Communication Skills

Team Leadership

Documentation

Ausbildung

Bachelor's degree in science/engineering/pharma

Tools

LIMS

Veeva QMS

SAP

MODA/LABVANTAGE

KNEAT

Jobbeschreibung

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 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.

Position Overview:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Lilly Kenosha County (LKC). This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. The Senior Associate, Quality Assurance – QA for QC provides quality oversight, assistance, and guidance to the Quality Control Laboratories on issues such as non-conformance investigations, change controls, procedure revisions, method activities (e.g., transfers, verifications, validation), and commissioning and qualification activities. This position is essential for maintaining GMP compliance and ensuring inspection readiness.

Responsibilities:

Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals. Leads, mentors, and coaches quality control laboratory personnel on quality matters. Supports the QA Compliance team and site in the execution of the site readiness plan with focus on right-first-time execution in the QC Laboratory. Reviews and approves laboratory instrument commissioning and qualification deliverables. Reviews and approves method deliverables including method transfers, verifications, and validations for QC Lab computer systems and equipment to ensure compliance with quality standards. Ensures regular presence in QC Lab areas to monitor GMP programs and quality systems. Serves as an active member on local lab team, as outlined in Lilly’s Manufacturing Standards for Operational Excellence, including participation with Lean Lab initiatives, daily huddle board and continuous improvement. Assess and triages deviations that occur within Quality Control. Works with Lilly support groups and external partners to resolve or provide advice on QC Lab related issues. Participates in self-led inspections and provides support during regulatory inspections. Works with the Global Quality Control laboratories and network personnel to benchmark and replicate best practices. Authors, reviews, and/or approves GMP documents in Quality Control to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation protocols, change controls). Participates in continuous improvement projects to help improve productivity within the local process team or quality organization.

Basic Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 5 years in the pharmaceutical industry with specific Quality Control experience.
• On-site presence required.

Additional Skills/Preferences:

• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.
• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing.
• Experience with LIMS, LES, SAP, Veeva QMS, Veeva Quality Docs.
• Proficiency with applicable laboratory management computer systems equivalent to MODA or LABVANTAGE.
• Demonstrated strong oral and written communication skills.
• Demonstrated interpersonal skills and the ability to work as a team.
• Root cause analysis/troubleshooting skills.
• Demonstrated attention to detail and ability to maintain quality systems.
• Proven ability to work independently or as part of a Team to resolve an issue.
• Technical Writing and Communication Skills.
• Previous regulatory inspection readiness and inspection execution experience.
• Computer System Quality Assurance (CSQA) experience or equivalent.
• Previous use of KNEAT – or equivalent electronic validation software.
• Previous facility or area start up experience.

Additional Information:

• Primary location is Kenosha County, Wisconsin
• Ability to travel (approximately 10 %)
• Ability to work overtime as required.

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly