S-Solutions Inc- a SyeDyn Company ยท 1 day ago
Data Integrity Specialist
Edison, NJ
Contract
Onsite
Mid Level
$45/hr - $50/hrS-Solutions Inc- a SyeDyn Company is seeking a Data Integrity Specialist to implement and maintain data integrity controls for HPLC systems. The role involves ensuring compliance with regulatory standards, leading OOS investigations, and performing content uniformity tests while maintaining accurate documentation and validated systems.
Information Technology & Services
Hiring Manager
Syed Rehman
Responsibilities
Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+ principles and regulatory standards (21 CFR Part 11, Annex 11)
Review audit trails, monitor user access, and perform periodic data reviews
Lead and coordinate Out-of-Specification (OOS) investigations (Phase I & II), including root cause analysis, hypothesis testing, and CAPA implementation
Perform titration-based content uniformity tests as 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 and audit trails
Maintain accurate documentation of chromatograms, integration parameters, and calculations
Document investigation narratives and track CAPA effectiveness
Review and approve titration method logs, normality calculations, and endpoint determinations
Qualification
Required
Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+ principles and regulatory standards (21 CFR Part 11, Annex 11)
Review audit trails, monitor user access, and perform periodic data reviews
Lead and coordinate Out-of-Specification (OOS) investigations (Phase I & II), including root cause analysis, hypothesis testing, and CAPA implementation
Perform titration-based content uniformity tests as 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 and audit trails
Maintain accurate documentation of chromatograms, integration parameters, and calculations
Conduct root cause analysis, hypothesis testing, and propose CAPAs
Document investigation narratives and track CAPA effectiveness
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
Company
S-Solutions Inc- a SyeDyn Company
S-Solutions Inc, is a leading entity in the staffing and recruiting industry, recognized for its commitment to connecting talented individuals with outstanding employment opportunities.
Founded in 2022
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase