Job Description:

Quality Systems Engineer - Supplier Quality










Date:

Jun 18, 2021









Location:

Maryland Heights, MO, United States

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About Curium

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

This roleis responsible forsupporting the Quality Systemsorganization in conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance. The position reports directly to theManager of Quality Systems.

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 multitask projects


• Ability to do simple to complex math calculations, input data into the computer and analyze data as required


• 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 andrequiringall employees to participate in safety programs designed to minimize potential and/or actual exposure levels.


• Responsibilities include the ability tolift upto 50 lbs., walk, bend, stoop, kneel, crouch, push, pull, reach, balance, climb stairs and ladders with or without accommodation.


• Must be able to work outside of regular work hours.


• May berequiredto 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 detailrequired.


• Mustpossessgood hand-eye coordination.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is anequal opportunity employerand believes everyone deserves respect, dignity and equality.All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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