Scientist – Warehouse Quality Assurance

Eli Lilly and Company; Alzey; Vor Ort; EUR 45.000 - 75.000; Vollzeit

Zusammenfassung

An established industry player is seeking a dedicated Scientist for Warehouse Quality Assurance in Alzey, Germany. In this pivotal role, you will ensure quality oversight of warehouse operations, manage quality functions, and support incoming material technicians. Your expertise in cGMP regulations and inventory management will be vital in maintaining compliance and efficiency. This position offers a unique opportunity to contribute to groundbreaking manufacturing initiatives while working in a collaborative environment. If you are passionate about quality assurance and looking to make a significant impact in the healthcare sector, this role is for you.

Qualifikationen

• 3+ years experience in pharmaceutical industry with warehouse focus.
• Strong understanding of cGMP regulations and quality assurance.

Aufgaben

• Manage quality oversight of warehouse operations and incoming materials.
• Document inspections and guide incoming technicians.

Kenntnisse

Quality Assurance

cGMP regulations

Inventory Management

Statistical Analysis

Ausbildung

Bachelor's degree in science or engineering

Tools

SAP

EWM

Jobbeschreibung

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.

Position Overview:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

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).

Additional Information:

• Primary location is Alzey, Germany.
• Ability to travel (approximately 10 %).
• Ability to work overtime as required.

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, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.