Data integrity Specialist jobs in United States
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Katalyst CRO ยท 1 day ago

Data integrity Specialist

positionEdison, NJ
timeFull-time
remoteOnsite
seniorityMid Level

Katalyst CRO is seeking a Data Integrity Specialist responsible for implementing and maintaining data integrity controls for HPLC systems in compliance with regulatory standards. The role ensures adherence to GLP, GMP, and good documentation practices while supporting validated systems and laboratory data accuracy.

AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon)
Ensure adherence to ALCOA+ principles and regulatory requirements (21 CFR Part 11, Annex 11)
Review audit trails, monitor user access, and perform periodic data reviews
Maintain accurate documentation of chromatograms, integration parameters, and calculations
Lead and coordinate Out-of-Specification (OOS) investigations (Phase I & II)
Conduct root cause analysis, hypothesis testing, and propose CAPAs
Document OOS investigation narratives and track CAPA effectiveness
Perform titration-based content uniformity tests per SOPs and pharmacopeial guidelines (USP, IP, BP)
Calculate active ingredient content and assess batch uniformity
Ensure compliance with GLP, GMP, and good documentation practices
Maintain validated systems with secure electronic records, audit trails, and backup protocols
Review and approve titration method logs, normality calculations, and endpoint determinations

Qualification

HPLC systemsData integrity complianceAudit trail reviewOOS investigationsGLP/GMP experienceTitration-based testingRoot cause analysisDocumentation practices

Required

Experience working in GLP/GMP-regulated laboratory environments
Hands-on experience with HPLC systems (Empower, Chromeleon)
Experience in data integrity compliance, audit trail review, and periodic data review
Experience leading OOS investigations (Phase I & II) and CAPA implementation
Experience performing titration-based content uniformity testing per pharmacopeial guidelines

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

H1B Sponsorship

Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)

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