Warehouse Associate II

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

As a Warehouse Associate II this individual supports the safe, compliant, and efficient movement of pharmaceutical products and raw materials within the warehouse environment. This role is responsible for receiving, storing, picking, packing, and shipping materials while adhering to strict regulatory requirements, including FDA, cGMP, and company SOPs. The Warehouse Associate plays a key role in maintaining inventory accuracy, ensuring product integrity, and supporting overall warehouse operations.

Key Responsibilities:

Receiving & Inventory Management
•    Receive incoming raw materials, components, and finished goods; verify accuracy against purchase orders and shipping documents.
•    Inspect incoming materials for damage, correct labeling, and compliance with specifications.
•    Accurately record inventory transactions in warehouse management systems (ERP). D365 experience is a plus.
•    Maintain organized storage areas according to cGMP, FEFO/FIFO, and safety guidelines.
Picking, Packing & Shipping
•    Pick and stage materials for production and customer orders following established SOPs.
•    Package products securely to maintain product integrity and meet quality standards.
•    Prepare shipping documentation (e.g., packing slips, waybills, BOL).
•    Coordinate with carriers to schedule and support outbound shipments.
Regulatory Compliance & Documentation
•    Follow all FDA, cGMP, OSHA, and company-specific compliance requirements.
•    Complete all required logs, forms, and electronic records accurately and in real time.
•    Support internal and external audits through proper documentation and workspace organization.

Material Handling & Equipment
•    Operate material-handling equipment such as pallet jacks, forklifts, reach trucks, or order pickers (with proper certification).
•    Ensure equipment is maintained in safe working condition and report any issues promptly.
•    Manage temperature controlled materials, including monitoring and documenting environmental conditions.
General Warehouse Operations
•    Maintain clean and hazard-free work areas in accordance with facility safety standards.
•    Participate in cycle counts and full physical inventory activities.
•    Collaborate with cross-functional teams including Quality, Manufacturing, and Supply Chain.
•    Support continuous improvement initiatives to enhance warehouse efficiency and compliance.
•    Serve as a role model for safety and GMP compliance.
•    Collaborate with Engineering, Automation, and Quality teams to support operational readiness.
•    Assist with troubleshooting and contribute to continuous improvement initiatives.
•    Ensure compliance with regulatory standards and adherence to established procedures.

As an individual contributor, you will take a compassionate and people-focused approach to your work, proactively collaborate with others to create a supportive and inclusive environment, and always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.

This role reports to the Director, Manufacturing

•    Executes warehouse operations in accordance with standard work and work instructions for monoclonal antibody (mAb) production.
•    Performs all tasks in accordance with Safety and Compliance policies, current Good Manufacturing Practices (cGMP), and Data Integrity principles (ALCOA+), as well as other applicable regulatory requirements. 
•    Escalates any actual or perceived non-compliance events, equipment issues, o