Senior QC Specialist: Analytical Methods & CAPA Leader

Katalyst CRO; Fort Worth (TX); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking a technical and quality systems leader within QC Operations Support in Fort Worth, TX. The role drives compliance, data integrity, and continuous improvement across QC labs and related functions.

You will oversee change control, CAPAs, method onboarding, and SME activities, collaborating across departments and with regulatory authorities to maintain cGMP standards.

Qualifications

• Bachelor's degree in science, engineering or related technical field required.
• 4+ years of related experience in pharmaceutical or similar regulated industry.
• Strong QC Microbiology experience preferred (testing, sampling, processes).
• Advanced knowledge in Statistical Analysis and cGMP standards; leadership and project management skills.

Responsibilities

• Perform Compendial Assessments.
• Author and Review Technical Documents.
• Design and Coordinate Analytical Method Onboarding Activities.
• Lead Qualification of Critical Materials, Instruments, and Equipment.
• Oversee Change Control Management.
• Manage Corrective and Preventive Actions (CAPAs).
• Serve as Subject Matter Expert (SME).
• Collaborate Across Departments.
• Drive Continuous Improvement Initiatives.
• Conduct Data Trending and Analysis.
• Represent QC on Global and Local Projects.
• Perform Other Duties Assigned by Leadership.

Skills

QC Microbiology

Leadership

Project management

Statistical Analysis

Regulatory communications

cGMP standards

Education

Bachelor's degree in science/engineering or related field

Job description

Katalyst CRO is seeking a technical and quality systems leader within QC Operations Support in Fort Worth, TX. The role drives compliance, data integrity, and continuous improvement across QC labs and related functions.

You will oversee change control, CAPAs, method onboarding, and SME activities, collaborating across departments and with regulatory authorities to maintain cGMP standards.