Curium Operations Quality Engineer II in Maryland Heights, Missouri
Summary of Position The Operations Quality Engineer II role is responsible for supporting the Quality Control organization in conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance. The position reports directly to the Quality Control Manager. Essential Functions * Lead investigator for Out of Specifications results * Identify and implement Corrective Actions * Lead investigator for Exceptions to Standard Operating Procedures * Generate or review Change Controls for Standard Operating Procedures, Standard Test Methods, Data Sheets, etc. * Employ the use of quality tools i.e. FMEA, Fishbone, 5 Why, Risk Analysis, HFAT, etc. in support investigations and special projects * Perform statistical analysis of laboratory data in support of investigations, cost savings, continuous improvement initiatives * Generate, execute and manage protocols for Method Validations, Equipment Qualifications * Work with radioactive materials * Ensure a safe and quality working environment through training, awareness, and compliance to safety/Quality guidelines and SOP s * Maintain current knowledge of federal and international regulations regarding Microbiology, Chemistry and cGMP's Provide support for FDA or other regulatory agencies for on-site audits Requirements * Bachelor of Science in Biology, Chemistry or related field required * Minimum 3+ years cGMP experience required * Experience investigating exceptions and out of specifications preferred * Must be able to resolve problems, handle conflict and make effective decisions under pressure * Root Cause Analysis * Action oriented/drives for results * Ability to do simple to complex math calculations, input data into the computer and analyze data as required * Ability to multitask projects * Must be proficient in use of Microsoft suite office products * Good computer skills, including utilizing personal computers and data entry programs * Good hands on, analytical, and problem solving and decision-making skills * Excellent writing and verbal communications skills * Ability to work independently and with others to accomplish goals and priorities * High level of energy and regular, consistent attendance * Verifiable working knowledge of cGMP guidelines and their application in a pharmaceutical manufacturing environment Working Conditions * 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 include the ability to lift up to 50 lbs., walk, bend, stoop, kneel, crouch, push, pull, reach, balance, and climb stairs and ladders without accommodation. * Must be able to work outside of regular work hours. * May be required to sit for long periods of time while performing duties. * Must be willing to wear a variety of personal protective equipment. * Willingness to work in a team based environment. * Close attention to detail required. * Must possess good hand-eye coordination. Competencies Solving Complex Problems Collaboration Integrity Commitment Displaying Technical Expertise Composing and Writing TextCurium 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.Employer's Job# 1941-33721391Please visit job URL for more information about this opening and to view EOE statement.