Senior Quality Engineer

Job Details – Location: Atlanta, GA 30313; Position Type: Full Time; Shift: Any. Responsible for product quality through proper design and implementation of appropriate procedures and specifications, as well as finished goods quality. Essential Duties and Responsibilities Authors, executes and reports on qualification/validations in the following areas: Equipment Qualifications Facility Qualifications Software Validation Computer System Validation Test Method Validations Stability Program Studies Human Factors Supports new product development teams to assure product quality is achieved through proper design, testing, and Engineering and Quality specifications. Assists in risk management program, assesses FMEA updates and controls Reviews/develops engineering test/qualification protocols, where required, to assure product/design changes are properly validated prior to release Supports process validation activities. Communicates and carries Quality Engineering philosophy to other internal groups Assures compliance to documentation procedures Reviews change requests Performs process capability analysis and assists in design of experiment activities Interfaces 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 required Qualifications Bachelor’s Degree in technical field and minimum 2 years related experience for Quality Engineer or 4 years for Sr. Quality Engineer; Master’s Degree Preferred. Strong knowledge of pharmaceutical manufacturing processes, computer and equipment validation, GMPs, and product/process validation. Test Method Validations Stability Program Studies 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 regulations Experience with laboratory environment, equipment, and safety procedures. Commitment to excellence and high standards Excellent verbal and written communications skills in English Ability to manage priorities and workflow Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm Acute attention to detail Demonstrated ability to plan and organize projects Ability to work independently and as member of various teams and committees Proven ability to handle multiple projects and meet deadlines Ability to develop clear, concise, and timely oral and written reports. Supervisory Responsibilities N/A Competencies Analytical—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 topics Change Management—Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results Quality Management—Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness. Physical Demands and Work Environment Ability to lift/move up to 50 pounds. #J-18808-Ljbffr Vero Biotech