Clinical Quality Specialist

Integrated Resources, Inc ( IRI ); Princeton (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Quality Operations Specialist to support critical R&D quality efforts. This role involves ensuring inspection readiness, managing quality metrics, and assisting with process improvements. The ideal candidate will possess excellent communication and problem-solving skills, demonstrating flexibility to manage multiple projects effectively. This is a fantastic opportunity to contribute to a dynamic team within the pharmaceutical and biotechnology sectors, where your expertise will directly impact the quality of research and development initiatives.

Qualifications

• Bachelor’s degree in science or a related field required.
• Excellent communication and problem-solving skills essential.

Responsibilities

• Support inspection readiness and quality metrics tracking.
• Manage updates to Good Clinical Practices and follow up on CAPA.

Skills

Communication Skills

Problem-Solving Skills

Interpersonal Skills

Flexibility

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Education

Bachelor’s degree in science

Tools

PowerBI

Job description

1 day ago Be among the first 25 applicants

Integrated Resources, Inc ( IRI ) provided pay range

This range is provided by Integrated Resources, Inc ( IRI ). Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$30.00/hr - $33.00/hr

Direct message the job poster from Integrated Resources, Inc ( IRI )

Lead Recruiter at Integrated Resources, Inc ( IRI )

Quality Operations Specialist I

Location : Princeton NJ

Duration : 9 months

Position Summary:

Responsible for assigned operational Quality Risk and Compliance (QRC) activities supporting Research and Development (R&D) quality efforts, including support of inspection readiness (IR), process improvement, quality metrics, and other assigned duties. Candidate will be required to work closely with internal R&D teams across all departments such as Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Drug Safety and Pharmacovigilance, Translational Sciences, Program Management, and Medical Affairs.

Primary Duties and Responsibilities:

• Inspection Readiness(IR) Support Tracking and closure of IR actions across multiple parallel workstreams, assist with meeting minutes, scheduling of meetings, trainings, etc.
• Manage updates to Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), Good Manufacturing Practices (GMP) SME Lists for Inspections, Follow-up on mock inspection Corrective and Preventive Actions (CAPA) closure and completion of lessons learned
• Quality Metrics Support: Follow-up with study teams on metrics responses
• Follow-up with teams with Spot Check responses due
• Follow-up on training due (based on PowerBI compliance metrics)
• Pull raw data from systems for metrics generation as requested
• Other Quality Operations Support: Follow ups for process improvement program
• Budget/invoice tracking for QRC, tracking of new and revised controlled documents – follow ups with curricula owners on training changes, processing of Adobe Forms
• Scheduling of quality related training workshops & Other internal meeting scheduling, minute taking, action item follow-ups as needed
• Other duties as assigned/required.

Skills & Requirement:

• Excellent communication skills, both verbal and written.
• Able to work independently as well as in cross-functional teams.
• Excellent pro-active, interpersonal, problem-solving, conflict resolving skills.
• Flexibility to switch between projects and assignments; ability to manage multiple projects, work streams and activities on a daily basis.
• Able to Product cooperation of others.
• Proficient computer skills, including Microsoft Word, PowerPoint and Excel.

Education:

• Bachelor’s degree in science or a related field.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Other

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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