Ecocareers ยท 1 week ago
Data integrity Specialist
Ecocareers is a company focused on maintaining data integrity in laboratory environments. The Data Integrity Specialist is responsible for implementing and maintaining data integrity controls for HPLC systems, ensuring compliance with regulatory standards and good documentation practices.
Staffing & Recruiting
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
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
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
Funding
Current Stage
Early StageCompany data provided by crunchbase