GCP Auditor, Quality Assurance jobs in United States
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Katalyst CRO ยท 1 day ago

GCP Auditor, Quality Assurance

positionHackensack, NJ
timeFull-time
remoteOnsite
seniorityEntry, Mid Level
date2+ years exp

Katalyst CRO is a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies, and they are seeking a GCP Quality Assurance Auditor. The role focuses on ensuring GxP compliance with regulatory authorities and involves conducting audits, supporting quality management systems, and collaborating with various stakeholders in the clinical trial process.

AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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Comp. & Benefits

Responsibilities

Plan and conduct global clinical process and vendor audits across clinical trials
Perform risk-based audits of specific clinical processes
Conduct clinical vendor audits with SMEs (e.g., IRT, EDC)
Develop and distribute audit reports to stakeholders
Own and manage clinical vendor non-conformances (CAPAs)
Review and audit compliance with FDA regulations, ICH-GCP, and related guidelines
Collaborate with clinical sourcing, supplier quality, and clinical partnerships
Support regulatory agency inspections
Participate in quality improvement initiatives

Qualification

GCP auditingPharmaceutical industry experienceInternalExternal auditsSOPsRisk-based auditing mindsetCommunication skillsDetail-oriented

Required

2+ years of pharmaceutical industry experience
Bachelor's degree in scientific, healthcare, or related discipline
Strong GCP and safety background
Experience with internal and external audits (process & systems)
Strong knowledge of SOPs, QMS, policies, and procedures
Ability to work with global clinical teams
10% travel required

Preferred

Extensive GCP auditing experience
Strong communication skills with internal teams and external partners
Detail-oriented with a risk-based auditing mindset

Company

Katalyst CRO

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Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
location
South Plainfield, New Jersey, USA
people-size51-200 employees
web-link
http://katalysthls.com

Funding

Current Stage
Growth Stage

Leadership Team

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John Patil
Recruiter, Pharma/CRO Staffing Division
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Recent News

LinkedIn
Katalyst HealthCares & Life Sciences on LinkedIn: Candidate Portal
2024-04-07
Company data provided by crunchbase