Warehouse Project Coordinator

WHAT WE ARE LOOKING FOR

The Warehouse Project Coordinator will operate in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

The Warehouse Project Coordinator is accountable for restoring and sustaining full compliance of the warehouse to cGMP (21 CFR Parts 210/211) and Good Distribution Practice (GDP) standards, remediating recent inspection findings, and embedding robust quality systems and lean operations. This role leads warehouse projects focused on compliance strategy, continuous improvement, and audit readiness while partnering with Quality, Production, and Supply Chain to ensure safe, compliant, and efficient material flow from receipt through distribution.

YOUR ROLE

• Own and execute the warehouse compliance remediation plan addressing FDA Form 483 and Warning Letter observations; drive timely, effective CAPA with documented effectiveness checks
• Establish, maintain, and continuously improve written procedures for receipt, identification, storage, handling, sampling, testing, approval/rejection, and distribution of components and drug products per 21 CFR 211.80, 211.82, 211.84, 211.142, and 211.150
• Implement and sustain physical and systematic status labeling and physical segregation for quarantine, approved, rejected, returned, and recalled materials; ensure lot/batch traceability to enable rapid recalls
• Ensure storage under appropriate temperature, humidity, and light conditions supported by stability data; manage temperature excursion evaluation and documentation
• Strengthen GDP practices for distribution, including FEFO/FIFO stock rotation, route qualification, and carrier oversight; verify proper transport conditions and chain of custody
• Own warehouse training program: role-based competency, cGMP/GDP, data integrity, and documentation practices; ensure training effectiveness and periodic assessment
• Lead self-inspection program and audit readiness, coordinate responses to regulatory inspections and partner audits
• Drive standard work, 5S, visual management, and waste elimination to improve Safety, Quality, Delivery, Cost (SQDC) while maintaining compliance
• Partner with Quality to trend deviations, change controls, complaints, returns, and recalls; implement risk-based preventive actions aligned with ICH Q9 principles
• Report compliance and performance metrics; communicate risks, mitigation plans, and progress to leadership; escalate critical issues promptly
• Performs other duties as assigned by management

YOUR BACKGRO UND

Required Qualifications

• Bachelor’s degree in Engineering, Supply Chain, Life Sciences, or a related field
• 7+ years of experience in GMP-regulated warehouse/materials management, including 3+ years leading compliance remediation or continuous improvement initiatives
• Expert knowledge of 21 CFR Parts 210/211 (Subparts E, H, J), GDP guidelines, and USP <1079> storage and shipping practices
• Demonstrated experience with temperature mapping/qualification of storage areas and excursion management
• Strong CAPA, change control, deviation investigation, and risk management skills; proven audit readiness leadership
• Proficiency with WMS/ERP systems and validated monitoring systems; strong data integrity and documentation practices
• Excellent communication, cross-functional collaboration, and stakeholder management skills

Preferred Qualifications

• Familiarity with ICH Q9 and ISPE guidance for controlled temperature chambers and quality systems
• Lean/Six Sigma certification (Green Belt or Black Belt)
• Experience with Sales & Operations Planning or Integrated Business Planning (IBP) processes in a GMP-regulated environment
• Experience working in a multi-site or global supply chain environment with complex distribution networks