Remote QA & Data Integrity Consultant (Preclinical)

Astrix; Town of Texas (WI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Remote work flexibility

Occasional site travel

Job summary

Astrix is seeking a Biopharma QA & Data Integrity Integration Consultant to oversee preclinical data workflows and data transfer validation. This role focuses on report-level completeness reviews, ALCOA++ compliance, and SDV practices to ensure traceable data reconstruction without scientific evaluation.

The ideal candidate has deep knowledge of Health Authority submissions (IND, CTA, CTN) and experience bridging paper records with modern systems (LIMS/ELN), while maintaining strict

Qualifications

• Hands-on QA experience reviewing preclinical and laboratory data.
• Deep familiarity with Health Authority submission processes (IND, CTA, CTN).
• Bridge between paper records and electronic lab systems (LIMS/ELN).
• Strict confidentiality with CROs/CDMOs and external partners.

Responsibilities

• Study Report & Data Completeness Review: verify inventories, structural components, and signatures.
• Data Transfer from Third Parties: ensure cross-border compliance and data ingestion controls.
• ALCOA++ Compliance: audit records across paper and electronic systems for traceability.
• Data Lifecycle Auditing: map data lineage from raw to reported data.

Skills

Hands-on QA Experience

Regulatory Mastery

Hybrid Data Review

Security & Confidentiality

Tools

LIMS

ELN

Job description

Astrix is seeking a Biopharma QA & Data Integrity Integration Consultant to oversee preclinical data workflows and data transfer validation. This role focuses on report-level completeness reviews, ALCOA++ compliance, and SDV practices to ensure traceable data reconstruction without scientific evaluation.

The ideal candidate has deep knowledge of Health Authority submissions (IND, CTA, CTN) and experience bridging paper records with modern systems (LIMS/ELN), while maintaining strict