Description The Team Lead - Kitting & Shipping will oversee day-to-day operations related to the preparation, assembly, packaging, and shipment of PCR reagent kits. This hands-on leadership role ensures that kitting and shipping activities are executed accurately, efficiently, and in compliance with quality standards and regulatory requirements. The ideal candidate brings strong organizational skills, attention to detail, and experience in a GMP or ISO-regulated life sciences or diagnostic manufacturing environment.
Position Responsibilities:
Kitting Operations
- Supervise and actively participate in the kitting of PCR reagent kits, including precise assembly of components (e.g., buffers, tubes, labels, accessories, packaging inserts).
- Review and execute kit assembly instructions, bills of materials (BOMs), and batch records with high attention to accuracy.
- Ensure kits are assembled according to SOPs and product specifications.
- Monitor inventory levels of kit components and proactively communicate shortages or discrepancies to stakeholders in MFG and Supply Chain
Shipping & Fulfillment
- Coordinate the accurate and timely fulfillment of customer orders, including packing, labeling, and documentation.
- Ensure that shipments meet cold chain requirements (e.g., dry ice or cold packs), where applicable, to preserve reagent integrity.
- Generate and verify shipping documentation (e.g., packing lists, shipping labels, export compliance forms).
- Collaborate with logistics providers (e.g., FedEx, UPS) to ensure on-time delivery
Team Supervision
- Provide day-to-day direction to kitting and shipping staff, including task assignment, schedule adherence, and productivity tracking.
- Train and onboard new team members on procedures, quality requirements, and safety practices.
- Conduct routine quality checks and ensure adherence to cGMP, ISO 13485, and internal quality systems.
- Maintain a clean, safe, and organized work environment according to 5S and lean principles.
Process Improvement & Documentation
- Identify and implement process improvements to enhance accuracy, throughput, and efficiency.
- Maintain and update SOPs, work instructions, and logs in coordination with Quality and Document Control.
- Support audits and inspections by providing accurate records and demonstrating process compliance
Minimum Requirements:
- High School Diploma or equivalent required;
- Associate or Bachelor's degree in Life Sciences, Logistics, or related field preferred.
- 2 years of experience in kitting, fulfillment, or logistics, preferably in a biotech, diagnostics, or GMP-regulated environment.
Knowledge, Skills, and Abilities
- Working knowledge of inventory control, shipping logistics, and order fulfillment processes.
- Proficiency in ERP systems (Netsuite and SAP), Microsoft Excel, barcode scanners, and shipping platforms (e.g., FedEx Ship Manager).
- Excellent organizational, communication, and problem-solving skills.
- Familiarity with PCR kits, reagents, and cold chain logistics is strongly preferred.
- Proven ability to lead small teams and maintain high standards of quality and productivity.
- Lean or Six Sigma experience is a plus.
|
bioMerieux Inc.
May 30, 2025