Quality Specialist - II

Join our Global Development Quality organization in Rahway, NJ as a Clinical Complaint Specialist within the Global Clinical Complaints team. Reporting to the Associate Director, this role is critical to supporting worldwide clinical trials by managing the end-to-end intake, documentation, coordination, and follow-up of distribution-related clinical complaints. You will act as a key liaison between clinical trial sites and internal stakeholders to resolve issues involving product shipments, temperature excursions, device malfunctions, and delivery errors. Operating in a flexible hybrid setup, we are looking for a detail-oriented candidate with a background in GMP, clinical supply, or quality operations who thrives on effective communication, accurate record-keeping, and driving timely complaint resolution.

Responsibilities

• Support the global clinical complaint management process for clinical supplies used in worldwide clinical trials under GMP guidelines.
• Receive, log, and process distribution-related clinical complaints—including shipment delays, delivery/transportation issues, and handling errors—in accordance with established procedures.
• Communicate directly with clinical trial sites and internal stakeholders to gather complete complaint details, obtain supporting documentation, and follow up through resolution.
• Review incoming complaint data for completeness and perform initial categorization and risk assessments using defined decision tools and criteria.
• Accurately enter, update, and maintain detailed complaint records within internal quality management systems.
• Route complaints to appropriate functional investigation teams and monitor timelines to ensure on-time closure of distribution-related issues.
• Coordinate technical clinical supply evaluations associated with distribution incidents, such as assessing product usability following temperature excursions or handling temperature device failures.
• Escalate complex issues and potential risks to leadership when appropriate, applying creative problem-solving to technical challenges.

Education

• Minimum Requirement: Bachelor’s degree (a technical emphasis in an appropriate scientific or engineering field is preferred).

Experience

Required Experience & Skills:

• 3 to 6 years of relevant post-degree experience in the Pharmaceutical or equivalent industry within a Good Manufacturing Practice (GMP) related field (e.g., Technical, Engineering, Quality, or Operations).
• Demonstrated ability to strictly follow established procedures, work instructions, and decision criteria with strong attention to detail.
• Effective written and verbal communication skills for liaising with clinical sites and internal teams.
• Strong organization and time-management skills to meet established project timelines and manage assigned tasks independently.
• Proficiency with core Microsoft applications (MS Excel, Outlook, and/or MS Access).
• Willingness and fast adaptability to learn specialized clinical supply and complaint-management software systems.

Preferred Experience & Skills:

• Previous experience in clinical supply, distribution logistics, customer service, complaint intake, or quality-related operations.
• Prior background in Quality Control (QC), Quality Assurance (QA), auditing, or regulatory affairs.
• Familiarity with clinical trials, clinical trial design, or clinical supply chain workflows.
• Experience utilizing quality and supply chain enterprise systems such as Veeva, TrackWise, SAP, or similar platforms.

Additional Information

• Job Title: Clinical Complaint Specialist – Global Development Quality
• Work Location: Rahway, NJ
• Work Arrangement: Hybrid (3 days on-site, flexible schedule)
• Team Focus: Global Clinical Complaints & Clinical Supply Chain