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

• 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
• Must have strong leadership, project and people management skills, and ability to make critical decisions
• Must have a strong understanding of business and/or industry