Supervisor – QA Incoming
- Durham, NC
- Permanent
- Full-time
- Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.
- Manage the QA – Incoming team, consisting of 8-12 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.
- High school diploma or GED
- 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.
- 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 12 hour days – rotating 2-2-3 shifts.
- Ability to work overtime as required.