Information Technology Quality Assurance

United Consulting Hub; New Jersey; On-site; USD 120,000 - 160,000; Part time

Job summary

United Consulting Hub in New Jersey seeks an experienced IT Quality Assurance Specialist/Lead to support GxP computerized systems and IT compliance in a pharmaceutical manufacturing environment. You will provide quality oversight for CSV/CSA, data integrity, change control, deviations, CAPA, audits, and system lifecycle management.

Responsibilities include ITQA oversight for SAP/ERP, MES, LIMS, QMS, SCADA, BMS/EMS, and laboratory systems; reviewing URS, validation plans, IQ/OQ/PQ, and validation

Qualifications

• Bachelor’s or Master’s degree in a related field.
• 5–10 years of ITQA, CSV, CSA, or GxP IT Compliance experience.
• Pharmaceutical or regulated life-sciences manufacturing experience.
• Strong knowledge of GxP, data integrity, validation lifecycle, change control, deviations, and CAPA.
• Experience with SAP, MES, LIMS, QMS, SCADA, PLC, BMS/EMS, or data historians.

Responsibilities

• Provide ITQA oversight for GxP computerized systems including SAP/ERP, MES, LIMS, QMS, DMS, SCADA, BMS/EMS, historians, and laboratory systems.
• Review and approve URS, risk assessments, validation plans, IQ/OQ/PQ, RTM, validation reports, and system release/retirement documents.
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU GMP Annex 11, ALCOA+, ICH Q9/Q10.
• Support CSV and CSA activities.
• Manage quality oversight for change controls, deviations, CAPA, incidents, periodic reviews, and system lifecycle activities.
• Evaluate data integrity, audit trails, user access, electronic signatures, backup/recovery, data migration, and disaster recovery controls.
• Support internal audits, supplier audits, FDA/regulatory inspections, and inspection readiness.
• Participate in vendor/cloud qualification and supplier compliance assessments.
• Collaborate with QA, IT, Manufacturing, Engineering, QC, Automation, Warehouse, and system owners.

Skills

ITQA

Quality Assurance

Data integrity

Change control

CAPA

Audits

Documentation

Analytical

Stakeholder management

System lifecycle

Education

Bachelor’s/Master’s in CS/IT/Engineering/Pharmacy/Life Sciences

Tools

SAP

MES

LIMS

QMS

SCADA

PLC

BMS/EMS

Data historians

Job description

Role:-IT Quality Assurance Specialist / Lead

Industry: Pharmaceutical Manufacturing (MUST)

Location: New Jersey,USA

Employment Type: 12+ Months W2 Contract

Experience: 5–10 Years

Job Summary:-

We are seeking an experienced IT Quality Assurance (ITQA) Specialist/Lead to support GxP computerized systems and IT compliance within a pharmaceutical manufacturing environment. The role will provide quality oversight for CSV/CSA, data integrity, change control, deviations, CAPA, audits, and system lifecycle management.

Key Responsibilities:-

• Provide ITQA oversight for GxP computerized systems, including SAP/ERP, MES, LIMS, QMS, DMS, SCADA, BMS, EMS, historians, and laboratory systems.
• Review and approve URS, risk assessments, validation plans, FS/DS, IQ/OQ/PQ, RTM, validation reports, and system release/retirement documents.
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU GMP Annex 11, ALCOA+, ICH Q9/Q10 and applicable GxP requirements.
• Support Computerized System Validation (CSV) and Computer Software Assurance (CSA) activities.
• Manage quality oversight for change controls, deviations, CAPA, incidents, periodic reviews, and system lifecycle activities.
• Evaluate data integrity, audit trails, user access, electronic signatures, backup/recovery, data migration, and disaster recovery controls.
• Support internal audits, supplier audits, FDA/regulatory inspections, and inspection readiness.
• Participate in vendor/cloud qualification and supplier compliance assessments.
• Collaborate with QA, IT, Manufacturing, Engineering, QC, Automation, Warehouse, and system owners.

Required Qualifications:-

• Bachelor’s/Master’s degree in Computer Science, IT, Engineering, Pharmacy, Life Sciences, or related field.
• 5–10 years of ITQA, CSV, CSA, or GxP IT Compliance experience.
• Pharmaceutical, biotech, medical device, or other regulated life-sciences manufacturing experience.
• Strong knowledge of GxP regulations, data integrity, validation lifecycle, change control, deviations, and CAPA.
• Experience with SAP, MES, LIMS, QMS, SCADA, PLC, BMS/EMS, or data historians is preferred.
• Strong documentation, analytical, communication, and stakeholder-management skills.

Preferred Certifications:-

GAMP 5/CSV, ASQ CQA, ITIL, ISO 27001, CISA, CISSP, or Project Management/Agile.