Education Minimum Requirement
" Bachelor degree, technical emphasis in an appropriate scientific or engineering field preferred;
Required Experience and Skills
Minimum of 3 to 6 years of relevant post-degree experience in the Pharmaceutical or equivalent industry (Good Manufacturing Practice (GMP) related field) including Technical, Engineering, Quality or Operations.
Ability to follow established procedures, work instructions, and defined decision criteria.
Strong attention to detail and ability to maintain accurate documentation.
Effective written and verbal communication skills, particularly when obtaining information and following up with internal stakeholders or clinical sites.
Ability to manage assigned activities and meet established timelines.
Ability to recognize issues requiring escalation and seek guidance when appropriate.
Effectiveness and creativity in approaching and solving technical problems.
Basic understanding of the use and maintenance of Microsoft applications (such as MS Excel, Outlook, and/or MS Access).
Demonstrated teamwork skills and the ability to work independently.
Willingness and ability to learn complaint-management and clinical-supply systems and processes.
Preferred Experience and Skills
Previous experience in clinical supply, distribution, logistics, customer service, complaint intake, or quality-related operations.
Previous experience in quality control, quality assurance, auditing or regulatory affairs.
Ability to independently manage multiple priorities.
Familiarity with clinical trials or the clinical supply chain.
Experience with systems such as Veeva, SAP, TrackWise, or other quality/supply-chain systems is preferred but not required.
Note:
Hybrid(3 days onsite flexible)
Rahway,NJ
Responsibilities
This position reports to the Associate Director, Global Clinical Complaints, Global Development Quality, and supports the clinical complaint process for clinical supplies used in worldwide clinical trials.
The primary focus of this role is the intake, processing, documentation, coordination, and follow-up of distribution-related clinical complaints, including issues associated with shipment, delivery, transportation and handling of clinical supplies
The individual will communicate with clinical sites and internal stakeholders to obtain required information, ensure complaints are accurately documented and routed to the appropriate investigating function, and monitor activities through completion.
Primary Responsibilities
Receive and process distribution-related clinical complaints in accordance with established procedures and work instructions.
Communicate with clinical sites and internal stakeholders to obtain required complaint information and supporting documentation to ensure they meet establish criteria for processing
Review complaint information for completeness and perform initial categorization using established criteria and decision tools.
Enter, maintain, and update complaint information within applicable complaint management systems.
Route complaints to the appropriate functional area for investigation and follow up in accordance with established procedures and to support timely completion and on-time closure of reported distribution complaint.
Support coordination of clinical supply activities associated with distribution-related complaints, including usability assessment of supplies impacted by temperature excursions during shipping, shipment issues/errors, shipments to incorrect destinations, temperature device malfunctions, etc.