QA – Stat Sort Lead 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.

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Concord, North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.

Responsibilities

The QA – Stat Sort Lead Specialist will have oversight of the daily operations of the Stat Sort group, development of QA Stat Sort Assistants, daily batch scheduling, and will provide assistance in deviation investigations, change control proposals, procedures, training, and will be an inspection SME resource. Additionally, the role will provide QA support of the start-up, commissioning, and qualification of the Concord site.

Key Objectives/Deliverables

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Responsible for Syringe Defect Kit Management, including Automated Inspection Challenge kits, and Inspection Qualification kits.
• Capable of functioning in Leader capacity in absence of Leader.
• Assist Leader in development of QA Stat Sort Assistants.
• Participate in planning / scheduling of QA Stat Sort operations and be a technical leader / resource for QA Stat Sort Assistants.
• Review GMP documents (example: Non-conformances, procedures, protocols, and change controls).
• Evaluate potential Product Quality impact for any GMP-related incident and support the investigations and assist with Safety investigations.
• Ensure Good Documentation practices and compliance with operational procedures and work instructions with Operations and support personnel.
• Perform inspection of Syringes.
• Participates in Six Sigma Projects and Process Improvement Initiatives to improve productivity within the Quality organization and the process team.
• Provide oversight and assist with training of new Parenteral site visual inspectors.
  
  
  

Basic Qualifications

• High School diploma or equivalent
• Demonstrated relevant experience in a GMP facility.
  
  
  

Additional Skills/Preferences

• Associate degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.
• Parenteral visual inspection experience
• Previous experience with deviation and change control process.
• Experience in Production, QC, QA, Technical Services, or Regulatory
• Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
• Experience as mentor or trainer
• Strong technical writing and oral/written communication skills
  
  
  

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

$28.12 - $46.88

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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