Posted on 17th March 2019
Quality Control Lab Coordinator
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!
Scope of Position:
The Quality Control Coordinator coordinates activities, schedules, projects in a radiopharmaceutical quality control laboratory. Facilitates learning opportunities of laboratory technicians, and confirms that safety and laboratory practices are followed. The Quality Control Coordinator further conducts quality control testing of raw materials, in process, finished product, and stability samples within the framework of site policies, departmental procedures, and current Good Manufacturing Practices (cGMP) regulations. Participates in investigations, team projects, and special project studies to accomplish company and departmental objectives. Records and reports data accurately and in compliance with current methods/Standard Operating Procedures (SOPs), United States Pharmacopeia (USP/NF), European Pharmacopeia and other compendia as applicable, and cGMP. Testing of instrumentation will include HPLC, GC, IC, ICP, AA, UV-VIS, Gamma Spectrometer, Dissolution, Dose Calibrators, Sodium Iodide Detectors, pH, balances, and TOC.
- Performs set up, calibration, operation, and maintenance of laboratory test instruments/equipment.
- Analyzes samples per established departmental/site/corporate policies, specifications, and procedures.
- Prepares solutions and standardizes test solutions as defined in analytical method or compendia.
- Performs assigned work in a timely and safe manner conforming to regulatory, company, and compendial requirements.
- May assist in routine verification of laboratory standards, solutions, and documentation.
- Practices cGMP, which includes, but is not limited to, proper laboratory documentation and maintenance, archival of documentation/raw data, attention to specification limits for any tests performed, and immediate notification of any out-of-specification (OOS) results.
- Complies reports/documentation of analytical tests, ensuring reports are accurate and complete with documentation of procedures, equipment/instruments, and reagents used in analytical testing.
- Demonstrates practical laboratory skills, and a thorough knowledge of chemistry theories, analytical techniques, and quality procedures.
- Reviews and revises SOPs, analytical methods and related procedures/documents.
- Follow environmental, health and safety (EHS) procedures and policies.
- The colleague will need to be trained working with Radioactive material.
- Associate Degree required in a scientific discipline; Bachelor Degree in Chemistry or related science field is highly preferred and some laboratory experience in a GMP regulated environment.
- Knowledge of compendia: USP, EP, and others as applicable, cGMP guidelines, FDA regulations; laboratory safety procedures, laboratory instrumentation, and SDS; knowledge of chemistry principals.
- Language Ability: Ability to read and understand applicable compendial methods (USP, EP, etc.), SOPs, general business periodicals, professional journals, technical procedures, and or governmental regulations; author scientific/technical reports, business correspondence and departmental procedures.
- Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals; perform simple statistical functions and graph data.
- Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions: interpret an extensive variety of technical instruction in mathematical or diagram forma and deal with several abstract and fixed variables.
- Computer Skills: To perform this job successfully, an individual should have knowledge of Windows based software applications such as Word, Excel, and Outlook. Knowledge of LIMs, and TrackWise. Knowledge and experience with Chromeleon is advantageous.
- 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 lift up to 50 pounds, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
- 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.
- Must possess good hand-eye coordination.
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 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.
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