QA Documentation Specialist III

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

Job Description

The QA Engineer is responsible for ensuring timely development, review, and approval of engineering, validation, and lifecycle documentation in alignment with corporate procedures, SOPs, cGMP, and industry best practices. This role supports manufacturing, engineering, validation, and quality teams by providing oversight across the full validation lifecycle, ensuring inspection readiness, and maintaining a compliant state for all equipment, utilities, systems, and processes. The QA Engineer plays a key role in supporting new installations, change controls, deviations, CAPAs, and continuous improvement initiatives.

Responsibilities

Quality Review & Documentation Oversight

• Review and approve engineering and validation documentation including IQ, OQ, PQ, PPQ, Validation Master Plans, risk assessments, calibration records, and periodic reviews.
• Create, review, and approve SOPs, Change Controls, CAPAs, deviations, forms, and reports.
• Ensure all documentation complies with corporate procedures, cGMP, and regulatory expectations.

Validation Lifecycle Support

• Support all phases of the validation lifecycle from design through operation, improvements, and revalidation.
• Participate in commissioning and qualification activities for new installations and systems, ensuring documentation meets cGMP and validation requirements.
• Provide QA oversight for computerized system validation, equipment qualification, utilities, automation, and laboratory instruments.

Cross Functional Collaboration

• Represent QA in multidisciplinary teams for facility build, laboratory moves, and validation projects.
• Collaborate with Manufacturing, Packaging, Engineering, MSAT, PD, and QA/QC to resolve process issues and implement changes.
• Work with internal and external engineering resources to ensure validation and compliance expectations are met.

Risk Management & Issue Resolution

• Identify, analyze, and manage risks throughout the product and equipment lifecycle using appropriate risk management tools.
• Assist in investigations and review deviation reports related to equipment, utilities, automation, computer systems, validation, and lab instruments.
• Support continuous improvement of GMP validation and change control programs.

Audit & Compliance Support

• Participate in internal, client, and regulatory audits.
• Maintain the site in a constant state of inspection readiness.
• Support site management in ensuring cGMP compliance across all operational areas.

Quality Metrics & Governance

• Establish, maintain, and report Quality KPIs and metrics.
• Participate in Management Review, Quality Review Board, Deviation Review Board, and Change Review Board.
• Perform additional tasks as assigned by the Senior Manager of QA Operations.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, or a related field (preferred).
• Additional training or certification in Quality Assurance, Validation, or cGMP is an advantage.
• 37 years of experience in Quality Assurance, Validation, or related roles within pharmaceutical, biotech, or regulated manufacturing environments.
• Strong understanding of cGMP, validation lifecycle, commissioning/qualification, and quality systems.
• Experience reviewing and approving validation protocols, change controls, deviations, and CAPAs.
• 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.