Scientist - Warehouse Quality Assurance

Scientist - Warehouse Quality Assurance

Eli Lilly

Alzey, Germany

The Scientist – Warehouse Quality Assurance provides quality oversight of warehouse operations. This QA associate directly manages quality functions as well as aids and guides incoming material technicians. The individual in this role advises on issues such as non-conformance investigations, change control proposals, procedures, and commissioning and qualification activities with a focus on Warehouse operations. This person will also support quality aspects within Warehouse operations associated with activities such as goods receipt, sampling of raw materials/GMP supplies (e.g., components, printed packaging materials), and outbound shipping processes. The individual in this role will be responsible for managing all quality-related matters associated with third party logistics partners.

Responsibilities:

• Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.
• Documents incoming inspections in accordance with procedures and specifications.
• Guides Incoming Technicians at the warehouse.
• Coaches and mentors support personnel.
• Assesses and triages deviations that occur within the warehouse area.
• Works with Lilly support groups and external partners to resolve or provide advice on receiving or shipping issues.
• Participates in self-led inspections and provides support during internal and external regulatory inspections.
• Provides Quality oversight of external warehouse functions to ensure compliance.
• Ensures materials not meeting specifications are quarantined per local procedures.
• Evaluates damaged materials found on inbound shipments or within the warehouse and determine acceptability.
• Evaluates temperature excursions on shipments received at the warehouse.
• Identifies and assists in resolving issues on shipments (e.g., incorrect quantity, incorrect product).
• Performs appropriate transactions in SAP to ensure system represents appropriate status of material (e.g., Quality Inspection, blocked, scrapped).
• Initiates complaints/remarks to supplier for materials not meeting Lilly expectations.
• May participate in investigations regarding materials or service complaints.
• Authors/revises procedures and materials specifications, as needed.
• Interacts with other functions and supports material related Supplier Change Notifications.
• Participates in/supports regulatory inspections, as needed.

Basic Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 3 years in the pharmaceutical industry with specific warehouse experience.
• Persons must be able to lift items up to 50 pounds.
• On-site presence required.

Additional Skills/Preferences:

• Demonstrated understanding of cGMP regulations related to QA Warehouse operations.
• Previous experience in GMP production and warehouse environments.
• Understanding of statistical tools and analysis.
• Experience in inventory management systems (e.g., EWM, SAP).

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