Curium Senior Operations Quality Engineer in Maryland Heights, Missouri
Summary of Position The Senior Quality Engineer position reports directly to the Manager of Quality Assurance. The Senior Quality Engineer is the primary Quality Operations contact to ensure quality compliance for manufactured products. The Senior Quality Engineer investigates or approves exceptions / out of specifications with root cause analysis tools to ensure appropriate corrective actions are identified to reduce / prevent recurrence. The Senior Quality Engineer supports or initiates continuous quality improvement activities. Schedule: This position will work on Sunday, Monday, Tuesday and Wednesday nights. Essential Functions * Review and approve Change Control/Quality Documents involving product or process changes. * Review and approve validations equipment, cleaning and/or process for assigned area. * Prepares and participates in regulatory agency i.e. FDA, etc. audits as well as internal audits. * QA contact for risk management activities, including FMEA s Failure Modes and Effects Analysis. * Investigate or serve as QA approver for customer complaints, exceptions / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented in the sites EQMS Electronic Quality Management System. * Assemble, analyze and report QA data to ensure regulatory compliance, identify trends and to identify areas of improvement. * Develop, review and/or revise SOP standard Operating Procedures, BR s Batch Records, STM Standard Test Methods, Specifications, FMEA s. * 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. Requirements * Bachelor Degree in Life Sciences or Engineering. * Minimum of 5-8 years of Quality experience in a pharmaceutical manufacturing environment * Significant experience investigating exceptions and other variances, using Quality Engineering Tools and Techniques i.e. RCA tools such as but not limited to 5-Whys, Fishbone/6M, TapRoot, Kepnor-Tregoe, Comparative Analysis * 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 is strongly preferred. * Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant out comes. * Must have experience with statistical tools. * Certification in Lean or Six Sigma preferred. 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.less thanbr>less thanbr>Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.less thanbr>less thanbr>less thanbr>less thanbr>less thanbr>Employer's Job# 1980-33700497less thanbr>Please visit job URL for more information about this opening and to view EOE statement.