Quality Specialist II – Clinical Complaints

Job Title: Quality Specialist – II

Duration: 24 Months

Location: Rahway, NJ 07065 Hybrid(3 days onsite flexible)

Pay Rate: $45/hr. on W2

Work Arrangement: Hybrid

Employment Type: Contract

Domain: Pharmaceutical

Application Deadline: November 13th, 2026

Description:

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.

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.

Key Points

• Role: Two-year contingent assignment supporting client’s Clinical Complaints Team, primarily handling distribution-related complaints.

• Responsibilities: Investigate temperature excursions, shipping errors, incorrect destinations, and temperature-device malfunctions; coordinate investigations, identify root causes, and support corrective actions.

• Schedule: Three days onsite and two remote. Wednesday is preferred, not mandatory. No travel.

• Collaboration: Work with the complaints team, clinical sites, West Point, Switzerland, and external partners such as Almac and Fisher.

Key Skills

• Investigation and analytical thinking: Gather evidence, connect findings, and draw supported conclusions.

• Attention to detail: Maintain accurate complaint records and meet closure timelines.

• Root-cause analysis and corrective actions.

• Communication and follow-through: Coordinate with internal sites and external suppliers through investigation completion.

• Teamwork, flexibility, and adaptability within a clinical environment.

• Complaint-system proficiency: Experience with the database transcribed as “Veeva” is beneficial, but training is available; confirm the product name.

Key Experience

• Product quality complaint experience is strongly preferred, even though the assignment focuses on distribution complaints—the processes use the same SOP.

• Pharmaceutical industry experience, preferably in clinical supplies or the clinical environment.

• Relevant exposure to distribution issues, temperature excursions, shipping investigations, and complaint handling.

• Commercial pharmaceutical experience remains acceptable; clinical experience is a preference, not a deal breaker.

BENEFITS

Medical | Dental | Vision | 401(k)

EEOC Compliance:

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment.

DISCLAIMER

AI Usage Policy: Pacer Group uses AI to assist in screening applications. Final hiring decisions are made by human recruiters based on qualifications and experience.