Pharma CSV QA Specialist: GMP Validation & Compliance

ASQ; Maryland; On-site; USD 90,000 - 130,000; Full time

Job summary

ASQ is seeking an experienced Computer System Validation (CSV) QA Resource to support quality assurance activities for computerized systems within a cGMP-regulated pharmaceutical manufacturing environment in Maryland.

The role requires strong CSV expertise, data integrity, and knowledge of FDA 21 CFR Part 11, GAMP 5, and EU Annex 11. You will review validation documentation and collaborate across IT, Engineering, Validation, and QA teams to maintain compliance.

Qualifications

• Bachelor's degree in a life sciences or engineering field.
• 5+ years in pharmaceutical/regulated manufacturing.
• Strong CSV and QA background.
• Solid knowledge of cGMP, Part 11, GAMP 5, Annex 11.
• Experience reviewing URS, FS, IQ/OQ/PQ and reports.
• Data integrity, electronic records, and e-signatures.

Responsibilities

• Provide QA oversight for CSV activities in GMP environment.
• Review and approve validation docs: URS, FS, IQ/OQ/PQ, reports.
• Ensure compliance with FDA Part 11, GAMP 5, Annex 11.
• Review data integrity controls, electronic records, and signatures.
• Support system lifecycle management including decommissioning.
• Review deviations, CAPAs, change controls, and investigations.
• Collaborate with IT, Engineering, Manufacturing, QC, Validation, and QA teams.
• Support internal and external audits and regulatory inspections.
• Maintain validated and compliant state of systems throughout lifecycle.

Skills

CSV QA

GMP compliance

Regulatory knowledge

QA documentation

Cross-functional collaboration

Data integrity

Audit support

Education

Bachelor's degree in Life Sciences / Engineering

Tools

Document management systems

Regulatory databases

Job description

ASQ is seeking an experienced Computer System Validation (CSV) QA Resource to support quality assurance activities for computerized systems within a cGMP-regulated pharmaceutical manufacturing environment in Maryland.

The role requires strong CSV expertise, data integrity, and knowledge of FDA 21 CFR Part 11, GAMP 5, and EU Annex 11. You will review validation documentation and collaborate across IT, Engineering, Validation, and QA teams to maintain compliance.