QA Materials Incoming/Disposition Associate

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.

Organization Overview:

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Responsibilities:

The QA Materials Incoming/Disposition Associate will report to the Associate Director Quality (Materials). This person will support activities including goods receipt, sampling, and outbound shipping process as well as perform incoming inspections including ID testing, sampling of raw materials/GMP supplies (components, printed packaging materials, etc.), and release of incoming materials utilizing SAP and Lab systems.

Key Objectives/Deliverables:

• Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.
• Documenting inspections in accordance with procedures and specifications.
• Ensuring materials not meeting specifications are quarantined, per local procedures.
• 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.  
• Evaluating temperature excursions on shipments received at the warehouse.
• Identifies and 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.)
• Initiates complaints/remarks to supplier for materials not meeting Lilly expectations.
• May participate in investigations regarding materials or service complaints.
• Authors/revises SOPs, materials specifications, as needed.
• Interacts with other quality functions and supports material related Supplier Change Notifications.
• Participates in/supports regulatory inspections, as needed.

Basic Qualifications:

• BA/BS degree required
• Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance.
• Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills.
• Strong attention to detail.
• Ability to work independently with minimal supervision.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the R path.

Additional Skills/Preferences:

• Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.
• Previous facility or area start up experience.
• Previous experience in GMP production and warehouse environments.
• Understanding of statistical tools and analysis.
• Experience in inventory management systems (EWM, SAP, etc.)
• Experience using Trackwise

Additional Information:

• Ability to work 12 hour shifts onsite on a rotating 2-2-3 schedule (not eligible for remote work).
• Overtime and off-shift support may be required.
• May be required to respond to operational issues outside of core business hours and days.
• May be subject to post-offer physical and vision exam.
• Job is exposed to repetitive movements such as: Walking, Sitting, Bending, Twisting.

This job description 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 description. For GMP purposes, the job description should be updated for significant changes.  As always, yo