Quality Specialist - II
agileone merckRahway, NJ
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
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