Laboratory Data Integrity Specialist

Stark Pharma Solutions Inc; Lowell (MA); Vor Ort; USD 90.000 - 150.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Data integrity assessments

Audit trails

21 CFR Part 11

Cross-functional collaboration

Tools

LIMS

CDS

Empower

LabWare

ELN

Jobbeschreibung

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position

Laboratory Data Integrity Specialist

Location

Massachusetts

Duration

Long Term

Job Overview

We are seeking a Laboratory Data Integrity Specialist with strong hands-on experience in Data Integrity Assessments and laboratory computerized systems. The ideal candidate should have strong knowledge of 21 CFR Part 11, ALCOA/ALCOA+, audit trails, electronic records, user access, and data flows.

Key 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.

Required Qualifications

• Strong hands-on experience with Data Integrity Assessments (DIA).
• Strong knowledge of 21 CFR Part 11 and ALCOA/ALCOA+ principles.
• Experience with laboratory and computerized systems.
• Experience using Data Integrity assessment templates and documenting findings.
• Experience drafting or reviewing Configuration Specifications.
• Knowledge of audit trails, electronic records, electronic signatures, user access, and data flows.
• Experience with laboratory systems such as LIMS, CDS, Empower, LabWare, or ELN is preferred.
• Knowledge of CSV/CSA, GAMP 5, and GxP is a plus.
• Strong analytical, documentation, and problem-solving skills.
• Good communication and cross-functional collaboration skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.