Quality Assurance Operations Specialist (Night Shift)

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.

Lilly is looking for experienced quality assurance associates to support our growth in Kenosha County, WI. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. The Quality Assurance Operations Specialist is responsible for providing QA oversight to GMP operations occurring on their respective shift (night). The role will demonstrate teamwork by collaborating cross functionally with various levels of the organization, supports issue resolution, and escalates issues from manufacturing to the site-based process teams for one of the following manufacturing areas:

• Formulation and Equipment Preparation Processes• Parenteral Filling (Pre-Filled Syringes)

The QA Specialist provides guidance on issues such as non-conformance investigations, change controls, procedures, validations, batch disposition, 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.

• Follows good documentation practices and compliance with site procedures. • Leads, mentors, and coaches the operations and support personnel on quality matters.

• Ensures regular presence in operational areas to monitor GMP programs and quality systems.

• Assess and triages deviations that occur within the local process team.

• Works with Lilly support groups and external partners to resolve or provide advice on product related issues.

• Participates in self-led inspections and provides support during regulatory inspections.

• Initiates, reviews, and approves documents to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation protocols, change controls, engineering documents).

• Participates in continuous improvement projects to help improve productivity within the local process team or quality organization.

• Approves commissioning, qualification, and validation documents for computer systems and equipment to ensure compliance with quality standards.

• Networks with Global Parenteral Network sites to benchmark and replicate best practices.

Basic Requirements:• Bachelor's degree in science, engineering, or pharmaceutical-related field of study.

• Minimum 3 years in the pharmaceutical industry with specific batch disposition experience.

• On-site presence required.

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills/Preferences:• Demonstrated understanding of cGMP regulations and experience in GMP production environments.

• Previous experience with C&Q and Validation oversight, including automation and computer systems validation.

• Knowledge and application of US, EU, Japan, and other pharmaceutical manufacturing regulations.

• Proficiency with applicable computer systems and Manufacturing Execution Systems.

• Experience with Computer System Quality Assurance (CSQA) and electronic validation software (e.g., KNEAT).

• Strong oral and written communication skills, including technical writing.

• Demonstrated interpersonal skills and ability to work effectively in a team environment.

• Ability to perform root cause analysis/troubleshooting and maintain quality systems with attention to detail.

• Proven ability to work independently or collaboratively to resolve issues.

• ASQ Certification. Additional Information:• Primary location is Kenosha County, WI.

• Ability to work 12-hour shifts (1800–0600) onsite on a rotating 2-2-3 or similar schedule on assigned shift (not eligible for remote work).

• Overtime and off-shift support may be required.

• May be required to respond to operational issues outside of core business hours and days.

• Ability to travel (approximately 10 %)

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$65,250 - $169,400

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.

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