Curium Operations Quality Engineer II in Maryland Heights, Missouri

About Curium:

Curium was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC. Curium is a world-class nuclear medicine solutions provider with over 100 years of combined industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service.

Our diverse group of industry experts is unified under one strong and singular focus – to develop, manufacture and supply SPECT, PET and therapeutic radiopharmaceuticals to customers around the globe. In fact, we have over 6,000 customers in over 70 countries world-wide.

At Curium, every single dose counts in helping doctors and patients diagnose and treat disease. That means every single employee counts toward meeting this unified objective to help each patient live “Life Forward”. We have an amazing team that lives by our core values every single day – integrity, commitment and collaboration. Our North American headquarters is in Maryland Heights, MO. Come grow with us!

Summary of Position:

The 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 with analytical chemistry techniques/methods and or experience with Microbiology techniques & methods strongly preferred.

  • 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 a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.

  • Standard office environment, coupled with time in radiopharmaceutical manufacturing and laboratory environments.

  • Must be willing to wear a variety of personal protective equipment.

  • Willingness to work in a team based environment.

  • Close attention to detail required.

  • May be required to sit or stand for long periods of time while performing duties.

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

  • Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.

  • Must possess good 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 an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.