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At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Lilly has a new state of the art Parenteral, Device, and Packaging Assembly Facility in Concord, North Carolina.  The QA Leader –Incoming Inspection is responsible for providing leadership to the Quality – Incoming Inspection team. The QA Leader – 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 8-10 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 (LabVantage, SAP 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 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 Senior Manager – Quality Assurance 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 WarehouseParticipates in/supports regulatory inspections, as needed.

Requirements (Education, Experience, Training):

High school diplomaExperience in Quality Assurance within cGMP environment

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 Concord site and will support a 24/7 operationAbility to support off-shift requestsAbility to work 8 hour days – Monday through Friday. Ability to work overtime as required. 

This job specification 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 specification.  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 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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