Quality Assurance Senior Specialist

Quality Assurance Senior SpecialistSerán is seeking a Quality Assurance Senior Specialist who will be responsible for performing the day-to-day tasks of the QA Department supporting a GMP facility manufacturing, storing, and testing pharmaceutical products. Primary responsibilities include overseeing Supplier Quality, Auditing (supporting regulatory and client audits, conducting internal and vendor audits), and managing the Quality Risk Management program. Tasks include audit management, audit response, facilitating audit related continuous improvements, negotiating/processing Quality Agreements and continuous improvement. Additional responsibilities include Quality Management System, risk analyses, change management and investigations/CAPA.Duties & ResponsibilitiesPerforms internal and third-party audits.Supports regulatory inspections and client audits. Manages and improves audit program.Provides direction on audit operational activities and the development of audit responses, CAPA plans, and Effectiveness Checks.Oversees company's supplier quality program including supplier qualification and audit (some travel required)Assists in the oversight, facilitation, and implementation of continuous improvement of the company's quality systemsAdministers the quality risk management program and conducts risk assessmentsDocument authorship, review, and approval of SOPs, reports, and quality records.Required Skills & AbilitiesKnowledge of GMP and FDA regulations for drug manufacturing (21CFR 210-211).Knowledge of GMP, FDA, and EMA expectations for clinical trial and commercial materials, manufacturing, and testingExcellent verbal and written communication skillsExcellent time management skills with a proven ability to meet deadlinesExcellent organizational skills and attention to detailDemonstrated ability to collaborate and work in cross-functional teamsScientific curiosity and willingness to learnStrong analytical and problem-solving skillsAbility to prioritize tasks and to delegate them when appropriateEducation & ExperienceMinimum of a Bachelor's Degree, preferably in a scientific discipline8+ years previous quality assurance experience including Auditing and Supplier Quality experienceWorking knowledge of Veeva preferredPhysical RequirementsProlonged periods of sitting at a desk and working on a computerMust be able to lift up to 15 pounds