Lab Data Integrity Specialist — Systems & Compliance

Stark Pharma Solutions Inc; Lowell (MA); On-site; USD 90,000 - 150,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Laboratory Data Integrity Specialist in Massachusetts for a long-term engagement.

The role focuses on hands-on Data Integrity Assessments (DIA) and review of laboratory computerized systems to ensure compliance with 21 CFR Part 11, ALCOA/ALCOA+ principles, and data integrity standards. You will collaborate with Quality, IT, and Laboratory teams to remediate findings.

Qualifications

• Strong hands-on experience with Data Integrity Assessments (DIA).
• Solid knowledge of 21 CFR Part 11 and ALCOA/ALCOA+ principles.
• Experience with laboratory systems and data integrity documentation.

Responsibilities

• Perform hands-on Data Integrity Assessments (DIA) for laboratory systems.
• Review laboratory computerized systems for data integrity compliance.
• Use Data Integrity assessment templates and document findings.
• Review audit trails, electronic records, electronic signatures, user access, and data flows.
• Draft and review Configuration Specifications.
• Assess laboratory systems and identify potential data integrity gaps.
• Support documentation and remediation of Data Integrity findings.
• Collaborate with Quality, CSV/CSA, IT, Laboratory, and other cross-functional teams.
• Support compliance with applicable GxP requirements and regulatory expectations.

Skills

Data integrity assessments

Audit trails

21 CFR Part 11

Cross-functional collaboration

Tools

LIMS

CDS

Empower

LabWare

ELN

Job description

Stark Pharma Solutions Inc. is seeking a Laboratory Data Integrity Specialist in Massachusetts for a long-term engagement.

The role focuses on hands-on Data Integrity Assessments (DIA) and review of laboratory computerized systems to ensure compliance with 21 CFR Part 11, ALCOA/ALCOA+ principles, and data integrity standards. You will collaborate with Quality, IT, and Laboratory teams to remediate findings.