Quality Assurance - Floor Support Specialist

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.

Responsibilities

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 Kenosha County, Wisconsin. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

Position Overview:

The Quality Assurance Floor Support Specialist works as a member of the QA Floor Support team and reports to the Associate Director of QA Parenteral Operations.  Responsibilities include providing QA oversight to GMP operations in the Parenteral equipment preparation, formulation, filling, and visual inspection areas.  The QA Floor Support Specialist oversees production functions to achieve site goals while providing Quality oversight and ensuring compliance.  

Key Objectives/Deliverables:

• Responsible for adhering to safety rules and maintaining a safe work environment for both ones-self and others by supporting HSE corporate and site goals.
• Responsible for ensuring training is completed and remains in compliance.
• Communicates with QA Process Team Leaders and AD of QA Parenteral Operations on quality and operational issues.
• Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.
• Advise Operations and support personnel on quality matters, while driving the site Quality culture.
• Ensures regular presence in assigned parenteral areas to monitor aseptic behaviors, GMP programs and quality systems.
• Reviews and approves GMP documentation in support of daily operations such as: electronic batch record logs, paper logbooks, cleaning, and procedures versus performance.   
• Performs daily documented Quality Checks.
• Perform sample collection, inspection, and delivery of samples to storage location and/or laboratory.
• Troubleshoot and provide QA systems support to reconcile issues in systems, such as, inventory control systems (SAP), laboratory LIMS system (Darwin) and other systems as required (TrackWise. PMX, Master Control, and Veeva).
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Ability to work cross functionally and work collaboratively with all levels of the organization.

Basic Qualifications

• High School Diploma or equivalent
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
• Completion of Post Offer Exam or Completion of Work Simulation if applicable.
• Ability to work overtime, as requested.

• 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 strong oral and written communication and interpersonal skills.
• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.
• Demonstrated knowledge and understanding of pharmaceutical process and Quality Systems.
• Knowledgeable with inventory management systems and deviations systems, (i.e. SAP, TrackWise, etc.)
• Previous work with combination products or devices with experience with US/EU regulations and notified bodies.
• Previous experience in GMP production environments.
• Previous facility or area start up experience.
• Knowledge of Validation / Qualification activities.
• Demonstrated decision making and problem-solving skills.
• Strong attention to detail
• Proven ability to work independently or as part of a team to resolve issues.

Additional Information

• May be required to respond to operational issues outside of core business hours / days.
• Applicant may work in various areas within the DAP and Warehouse buildings. Mobility requirements should be considered when applying for this position.

This job description is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes.  As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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

$18.02 - $34.90

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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