QA Documentation Lead — Validation & Compliance

Katalyst CRO; Tampa (FL); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO in Tampa, FL seeks a QA Engineer to oversee documentation, validation, and regulatory readiness across engineering, validation, and manufacturing teams.

You will review and approve validation protocols, change controls, deviations, and CAPAs while ensuring cGMP compliance and quality systems across equipment and processes. This role emphasizes cross-functional collaboration and continuous improvement.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, or related field.
• Experience in Quality Assurance, Validation, or cGMP is advantageous.
• Experience reviewing and approving validation protocols, change controls, deviations, and CAPAs.
• Strong understanding of cGMP, validation lifecycle, commissioning/qualification, and quality systems.
• Familiarity with equipment qualification, utilities, automation systems, and computerized system validation.
• Experience supporting audits and maintaining inspection readiness.
• Strong communication, documentation, and crossfunctional collaboration skills.

Responsibilities

• Review and approve IQ, OQ, PQ, and PPQ documents and validation plans.
• Create or update SOPs, change controls, CAPAs, deviations, forms, and reports.
• Ensure documentation complies with cGMP and regulatory expectations.
• Support all phases of the validation lifecycle from design to operation and revalidation.
• Collaborate with Manufacturing, Engineering, QA/QC to resolve issues.
• Participate in audits and maintain site inspection readiness.
• Establish and report Quality KPIs and governance metrics.

Skills

Quality Assurance

Validation

cGMP

Documentation

Cross-functional Collaboration

Audits

Risk Management

Regulatory Compliance

Validation Protocols

Education

Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, or related field

Certification in Quality Assurance/Validation/cGMP

Tools

IQ/OQ/PQ/PPQ

Validation Master Plans

Calibration Records

SOPs

CAPA tracking systems

Job description

Katalyst CRO in Tampa, FL seeks a QA Engineer to oversee documentation, validation, and regulatory readiness across engineering, validation, and manufacturing teams.

You will review and approve validation protocols, change controls, deviations, and CAPAs while ensuring cGMP compliance and quality systems across equipment and processes. This role emphasizes cross-functional collaboration and continuous improvement.