Senior Quality Control Specialist

Katalyst CRO; Social Circle (GA); Vor Ort; USD 100.000 - 150.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

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).
• 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.

Kenntnisse

QC Microbiology

Project management

Leadership

Statistical analysis

cGMP knowledge

Regulatory knowledge

Communication skills

Ausbildung

Bachelor's degree in science/engineering

Jobbeschreibung

Job Description

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

• 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.
• Perform Other Duties Assigned by Leadership.

Job Description

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

Important Specifications

• 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.