Senior QC Quality Systems Lead & CAPA Authority

Katalyst CRO; Social Circle (GA); On-site; USD 100,000 - 150,000; Full time

Job summary

Katalyst CRO in Social Circle, GA seeks a Technical and Quality Systems Leader within QC Operations Support. You will drive compendial assessments, author/ review technical documents, and coordinate analytical method onboarding.

Lead qualification efforts, oversee change control, manage CAPAs, and serve as SME. You will trend data, represent QC on projects, and collaborate across departments to push continuous improvement.

Qualifications

• Requires bachelor's degree in science, engineering or related technical field with 4+ years of related experience.
• Strong QC Microbiology experience preferred (testing, sampling, processes).
• Knowledge of quality lab operations and regulations pertaining to pharmaceutical and medical device manufacturing labs.
• Ability to manage multiple tasks and responsibilities for the QC Lab.
• Excellent technical and interpersonal communication with regulatory authorities.
• Advanced knowledge in statistics and cGMP standards.

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).
• Conduct Data Trending and Analysis.
• Represent QC on Global and Local Projects.
• Collaborate Across Departments and Drive Continuous Improvement.
• Perform Other Duties Assigned by Leadership.

Skills

QC Microbiology

Project management

Leadership

Statistical analysis

cGMP knowledge

Regulatory knowledge

Communication skills

Education

Bachelor's degree in science/engineering

Job description

Katalyst CRO in Social Circle, GA seeks a Technical and Quality Systems Leader within QC Operations Support. You will drive compendial assessments, author/ review technical documents, and coordinate analytical method onboarding.

Lead qualification efforts, oversee change control, manage CAPAs, and serve as SME. You will trend data, represent QC on projects, and collaborate across departments to push continuous improvement.