Senior Quality Control Specialist

About the role

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

• 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).

Skills

• Knowledge of quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs.
• Ability to manage multiple tasks and responsibilities for the QC Lab.
• Ability to manage complex projects and resolve complex lab issues.
• Excellent technical and interpersonal skills, with ability to communicate with all level personnel and regulatory authorities.
• 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.