Supervisor – QA Incoming

Eli Lilly and Company; Concord (NC); On-site; USD 50,000 - 90,000; Full time

Job summary

Join a forward-thinking company that is dedicated to improving lives through innovative healthcare solutions. As a QA Leader in Incoming Inspection, you will play a crucial role in overseeing the quality of incoming materials at a state-of-the-art facility. This position offers the opportunity to lead a dynamic team, ensuring compliance with stringent quality standards while fostering a culture of safety and excellence. If you're passionate about quality assurance and want to make a meaningful impact in the healthcare industry, this role is perfect for you. Embrace the chance to grow your career in a supportive and collaborative environment where your contributions truly matter.

Qualifications

• Experience in Quality Assurance within cGMP environment is essential.
• Strong attention to detail and ability to manage multiple tasks.

Responsibilities

• Lead the QA – Incoming team for incoming materials inspection.
• Ensure compliance with cGMP regulations and training requirements.

Skills

Quality Assurance

cGMP Regulations

Team Leadership

Attention to Detail

Computer System Applications

Statistical Tools

Inventory Management Systems

Education

High School Diploma

Tools

SAP

LabVantage

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 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.

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 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 Warehouse.
• Participates in/supports regulatory inspections, as needed.

Requirements (Education, Experience, Training):

• High school diploma.
• Experience 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 operation.
• Ability to support off-shift requests.
• Ability 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.