Senior Quality Control Specialist

Katalyst CRO; Fort Worth (TX); Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

QC Microbiology

Leadership

Project management

Statistical Analysis

Regulatory communications

cGMP standards

Ausbildung

Bachelor's degree in science/engineering or related field

Jobbeschreibung

Job Description

This position functions as the technical and quality systems leader within QC Operations Support.

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.

Requirements

• Requires bachelor's degree in science, engineering or other related technical field. 4+ years of related experience in pharmaceutical or similar regulated industry.
• Strong QC Microbiology experience preferred (testing, sampling, processes.
• Key Skills, Abilities, and Competencies:
• Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs.
• Must have the ability to manage multiple tasks and responsibilities for the QC Lab.
• Must have the ability of managing complex projects and resolving complex lab issues.
• Must possess excellent technical and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities.
• Should have advanced knowledge in Statistical Analysis and cGMP standards. Strong leadership, project and people management skills, and ability to make critical decisions.
• Strong understanding of business and/or industry.