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. Responsibilities 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. Requirements 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. #J-18808-Ljbffr