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Curium Principal Operations Quality Engineer in Maryland Heights, Missouri

Summary of Position The Principal Operations Quality Engineer position is responsible for the oversight and primary SME for all quality systems used for our business. This position requires strong technical and training skills for site quality systems. Knowledge in pharmaceutical quality systems with proficiency in quality oversight of a minimum of 50% of the following: Stability, Change Control/Regulatory, Supplier Relations, Internal Auditing, Corrective Action Program, Exceptions, Out of Specification Investigations, Customer Complaints, Document Control and Annual Product Reviews. Schedule: This position will work on Sunday, Monday, Tuesday and Wednesday nights. Essential Functions * Take a leadership role for site/corporate development and maintenance of facility s quality systems and procedures. * Review and approve Change Control/Management Documents involving product or process changes. * Key personnel for FDA or other regulatory agencies for on-site audits. * Provides New Hire cGMP Training. * Drive for resolution of product complaints, exceptions, corrective actions, and/or safety issues. * Assemble, analyze and report QA system data to ensure regulatory compliance, identify trends and to identify areas of improvement. * Conduct quality audits and develop and assess subsequent corrective action recommendations. * Developing procedures, statistical evaluations, and remediation of systems. * Ability to adapt quickly in a fast paced dynamic environment. * Ability to communicate with and positively influence broad and diverse populations within and outside the organization. Ensure a safe and quality working environment through training, awareness and compliance to safety guidelines and SOP s. * Ensure the maintenance of the department, premises and equipment. * Additional areas of responsibility may include developing specifications test methods, sampling plans and standard operating procedures; providing quality system training; actively participating in Material Review Board meetings; and assisting Corporate Product Monitoring in preparation of regulatory submissions. Requirements * Bachelor Degree in Life Sciences or Engineering. * Minimum of 8-12 years Quality experience in a finished pharmaceutical manufacturing environment with strong understanding of and exposure to applicable quality systems. * Minimum of 3-5 years experience in supporting on-site inspections for regulatory agencies. * Significant experience investigating exceptions and other variances. * Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems. * Working knowledge of cGMP guidelines and their application in a controlled aseptic environment. * Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes. * Must have experience with statistical tools. Proficient in use of Microsoft suite of products. * Must possess strong problem solving, decision making, verbal and written communications skills. * Results-oriented, able to make decisions and prioritize work per business needs in a fast paced environment. * Good analytical and problem-solving skills. * Strong communication, organization and time management skills. Working Conditions * Standard office environment, coupled with approximately 25% time in clean room, radiopharmaceutical manufacturing, and laboratory environments. * Must be willing to wear a variety of personal protective equipment. * Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels. * Responsibilities also include the ability to sit, stand, walk, bend, push, pull, reach, and climb stairs without accommodation. * May be required to sit or stand for long periods of time while performing duties.Curium is an equal opp

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