Quality Assurance - Floor Support Specialist

Eli Lilly and Company • Pleasant Prairie, WI

4d • $18 - $35

About The Position

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.

Requirements

• 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
• Demonstrated strong oral and written communication and interpersonal skills.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees