Senior Quality Engineer

Responsible for product quality through proper design and implementation of appropriate procedures and specifications, as well as finished goods quality.Essential Duties and ResponsibilitiesAuthors, executes and reports on qualification/validations in the following areas:Equipment QualificationsFacility QualificationsSoftware ValidationComputer System ValidationTest Method ValidationsStability Program StudiesHuman FactorsSupports new product development teams to assure product quality is achieved through proper design, testing, and Engineering and Quality specificationsAssists in risk management program, assesses FMEA updates and controlsReviews/develops engineering test/qualification protocols, where required, to assure product/design changes are properly validated prior to releaseSupports process validation activities.Communicates and carries Quality Engineering philosophy to other internal groupsAssures compliance to documentation proceduresReviews change requestsPerforms process capability analysis and assists in design of experiment activitiesInterfaces with Product and R&D Engineering groups on design and specification-related issues as well as for approvals, as required.Works closely with Quality System personnel to assure compliance with quality system requirements.Performs other duties and responsibilities, as requiredBachelor’s Degree in technical field and minimum 2 years related experience for Quality Engineer or 4 years for Sr. Quality Engineer; Master’s Degree PreferredStrong knowledge of pharmaceutical manufacturing processes, computer and equipment validation, GMPs, and product/process validation.ASQ Certification preferred.Knowledge of quality engineering principles.Ability to analyze component and final product processes to improve overall efficiency and quality..Thorough knowledge of GMP, CFR, and factors impacting compliance.Knowledge of and ability to utilize statistic in evaluation of data.Thorough knowledge of FDA regulationsExperience with laboratory environment, equipment, and safety procedures.Commitment to excellence and high standardsExcellent verbal and written communications skills in EnglishAbility to manage priorities and workflowVersatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasmAcute attention to detailDemonstrated ability to plan and organize projectsAbility to work independently and as member of various teams and committeesProven ability to handle multiple projects and meet deadlinesAbility to develop clear, concise, and timely oral and written reports.Supervisory ResponsibilitiesN/ACompetenciesAnalytical-Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.Problem Solving-Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topicsChange Management—Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates resultsQuality Management-Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.Physical Demands and Work EnvironmentAbility to lift/move up to 50 pounds #J-18808-Ljbffr Vero Biotech