Supervisor - QA Incoming

Company: Eli Lilly
Location: Denver
Posted on: May 28, 2023

Job Description:

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 35,000 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 has a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. The QA Supervisor -Incoming Inspection is responsible for providing leadership to the Quality - Incoming Inspection team. The QA Supervisor - Incoming will oversee the incoming materials, including goods receipt, sampling, incoming inspections/testing, and inbound/outbound shipping processes.
Key Objectives/Deliverables:

• Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.
• Manage the QA - Incoming team, consisting of 4-6 Quality Specialists.
• Responsible for training and managing the QA - Incoming team in:
  • Performing incoming inspections (raw materials, components, printed packaging materials, etc.) according to priority.
  • Documenting inspections in accordance with procedures and specifications.
  • Ensuring materials not meeting specifications are quarantined, per local procedures.
  • Sampling, inspecting, and documenting results utilizing electronic systems (Darwin, SmartLab, etc).
  • When sampling a portion of the batch, ensure proper sampling plan is followed.
  • Working with the QC Lab to deliver samples and receive results
  • Performing ID testing of materials utilizing Raman or NIR Spectroscopy.
  • Maintaining retains and samples per local procedures.
  • Communicate with QA Disposition team to ensure materials are released in a timely manner, as to not delay production.
  • Evaluating damaged materials found on inbound shipments or within the warehouse and determine acceptability.
  • Ensuring storage condition is tracked, accurate, adjusted (as needed) including evaluating temperature excursions on shipments received at the warehouse.
  • Assists in resolving issues on inbound shipments (i.e.incorrect quantity or product, contamination, etc.).
  • Performs appropriate transactions in SAP to ensure system represents appropriate status of material (QI, blocked, scrapped, etc.)
  • Provides additional Quality support to warehouse, as necessary.
  • May need to assist with performing department activities to ensure materials are available for production.
  • Responsible for ensuring team is trained and training remains in compliance.
  • Communicates with Associate Director and Quality Representatives on quality issues.
  • Lead, mentor, and coach QA - Incoming team, Operations, and support personnel on quality matters, while supporting and driving the site Quality culture.
  • Ensure regular presence in operational areas to monitor GMP programs and quality systems.
  • Work with materials management group to initiate complaints/remarks to supplier for materials not meeting Lilly expectations.
  • May participate in investigations regarding materials or service complaints.
  • Networks with the business and ensures all materials are dispositioned in a timely manner to support production schedule.
  • Authors/revises SOPs, materials specifications, as needed.
  • Interacts with other quality functions including QA Warehouse
  • Supports material related Supplier Change Notification's (SCN).
  • Participates in/supports regulatory inspections, as needed. Requirements (Education, Experience, Training):
    • High school diploma or GED Preferred attributes but not required:
      • Previous materials or warehouse experience.
      • Previous experience leading and managing a team.
      • Demonstrated understanding of cGMP regulations related to QA Inspection applications.
      • Strong attention to detail.
      • Proficient in computer system applications.
      • Ability to organize and prioritize multiple tasks, highly flexible and able to work independently in fast paced environment to support production demands.
      • Excellent interpersonal and networking skills.
      • Highly motivated, enthusiastic, share ideas and lead solutions effectively to resolution; ensure safety of others.
      • Understanding of statistical tools and analysis.
      • Experience in inventory management systems (SAP, etc.)
      • Previous experience in GMP production environments.
      • Previous facility or area start up experience.
        Other Information:
        • The position is for the Lilly Research Triangle Park site and will support a 24/7 operation
        • Ability to support off-shift requests
        • Ability to work 8 hour days - Monday through Friday.
        • Ability to work overtime as required.
          Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
          Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
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Keywords: Eli Lilly, Denver , Supervisor - QA Incoming, Other , Denver, Colorado