CSV QA Specialist

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

Job Summary

Seeking an experienced Computer System Validation (CSV) QA Resource to support Quality Assurance activities related to computerized systems within a cGMP-regulated pharmaceutical manufacturing environment.

The individual will provide QA oversight and ensure computerized systems are validated, compliant, and maintained in accordance with applicable regulatory requirements, including FDA 21 CFR Part 11, GAMP 5, and EU Annex 11.

The ideal candidate will have a strong background in pharmaceutical QA, Computer System Validation (CSV), data integrity, and GMP compliance, with experience reviewing and approving validation documentation.

Key Responsibilities

• Provide Quality Assurance oversight for Computer System Validation (CSV) activities in a GMP-regulated environment.
• Review and approve computerized system validation documentation, including User Requirement Specifications (URS), Functional Specifications (FS), risk assessments, IQ/OQ/PQ protocols, and validation summary reports.
• Ensure computerized systems comply with FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and applicable cGMP regulations.
• Review and assess data integrity controls, electronic records, and electronic signatures.
• Support system lifecycle management, including system implementation, periodic reviews, change controls, and decommissioning.
• Review and approve deviations, CAPAs, change controls, and validation-related investigations.
• Collaborate with IT, Engineering, Manufacturing, QC, Validation, and other QA teams.
• Support internal and external audits and regulatory inspections.
• Ensure computerized systems remain in a validated and compliant state throughout their lifecycle.

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Computer Science, or a related discipline preferred.
• 5+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
• Strong experience in Computer System Validation (CSV) and Quality Assurance.
• Thorough understanding of cGMP, FDA 21 CFR Part 11, GAMP 5, and EU Annex 11.
• Experience reviewing and approving validation documentation, including URS, FS, IQ, OQ, PQ, and validation reports.
• Knowledge of data integrity principles, electronic records, and electronic signatures.
• Experience with deviations, CAPA, change control, risk assessments, and audit support.
• Strong technical documentation, communication, and cross-functional collaboration skills.

Preferred Qualifications

• Experience with computerized systems such as MES, LIMS, ERP/SAP, SCADA, and laboratory systems.
• Experience supporting CSV activities in pharmaceutical manufacturing or laboratory operations.
• Knowledge of software/system lifecycle management and risk-based validation approaches.
• Experience in FDA-regulated pharmaceutical or biologics manufacturing environments.