Senior Quality Control Specialist

Job Description

The role of the Senior Quality Control Specialist is to provide technical expertise and support for the operational support functions of the QC Laboratory.

• Perform compendial assessments to ensure compliance with current regulatory requirements and pharmacopeia standards.
• Author and review technical documents, including protocols, standard operating procedures (SOPs), and analytical methodologies.
• Design and coordinate analytical method onboarding activities, including execution planning, training, and documentation.
• Lead and manage the qualification of critical materials, analytical instrumentation and equipment, ensuring fitness for use in analytical testing.
• Oversee change control management processes, including risk assessment, documentation, and implementation.
• Manage Corrective and Preventive Actions (CAPAs) related to analytical processes and support timely closure of quality events.
• Act as a Subject Matter Expert (SME) by providing technical guidance and troubleshooting support to laboratory testing teams.
• Collaborate effectively across departments to ensure alignment and successful execution of cross‑functional initiatives.
• Identify and drive continuous improvements in analytical methods and laboratory workflows to enhance efficiency and compliance.
• Conduct data trending and analysis of laboratory processes and analytical performance on a routine basis to identify trends and areas for improvement.
• Serve as a QC representative with global teams on both global and local projects and take the initiative for improvements.
• Perform all other duties as assigned by Leadership.

• Bachelor’s degree in science, engineering or other related technical field.
• 4+ years of related experience in the pharmaceutical or a similarly regulated industry.
• Strong QC microbiology experience preferred (testing, sampling, processes).
• 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 and ability to communicate with personnel at all levels 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.

This position is in compliance with equal employment opportunity laws and is required by law to provide reasonable accommodations to qualified applicants with disabilities.