Senior Quality Control Specialist

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.

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.