Posted on 31st July 2019
Quality Control Supervisor
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. Come grow with us!
Summary of Position
The Quality Control Supervisor for Night Shift Chemistry at the Maryland Heights Pharmaceuticals facility is responsible for leading the night shift Quality Control team to ensure compliance with all Corporate and Local policies, procedures and regulations. While supervising in a cGMP environment, this position must maintain operational compliance with U.S. and international regulatory agencies (i.e. FDA, NRC, BDB, DHSS, etc.).
The Quality Control Supervisor will also schedule laboratory testing and provide resource and instrumentation allocation, conducts laboratory investigations, implements and monitors corrective actions. This role provides timely testing and notification of any aberrant occurrence to Management that presents potential negative impact to manufactured or marketed product. The supervisor will monitor and maintain quality programs that provide assurance that test specifications are met for raw materials, components, finished products, intermediates, stability, and validation testing.
The schedule for this position is Saturday evening through Wednesday morning, 8 PM to 6:30 AM.
- Work cross functionally to coordinate testing schedules and communications in support of the weekly production activities and ensure QC testing and maintenance activities are completed per requirements.
- Schedule and ensure testing of production, raw materials, components, stability, validation and support of protocol/experimental samples.
- Verify, review and make appropriate changes if needed, to any controlled document(s) pertinent to area of responsibility.
- Ensure team compliance with all policies, procedures and site/company regulations.
- Support investigations of process or product failures and customer complaints. Author, and/or review all area quality and safety exceptions and investigation reports. Facilitate on time completion of all corrective action items assigned to area.
- Work safely with radioactivity and ensure all direct reports maintain radiological exposure to levels As Low As Reasonably Achievable (ALARA).
- Coach and develop the team to High Performance while fostering a culture of team ownership. Recognize and reward performance.
- Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member’s performance management.
- Provide leadership for employees through effective communication, coaching, training and development and provide solutions for the success of the team.
- Conduct daily Huddle board meetings to update employees and track progress.
- Measure and communicate team progress against individual, team and site goals and Key Performance Indicators (KPI’s).
- Manage the department overtime (OT) and ensure that all exception reports are completed and submitted as required.
- Maintain an acceptable level of 5S in the area and promote proper maintenance and cleanliness of the department areas of responsibility.
- Assure compliance with department training and qualification.
- Bachelor level degree required, in a science or engineering related field, advanced degree preferred.
- At least 5 years of experience in a cGMP regulated environment, some level of leadership experience required.
- Proficiency in cGMP laboratory testing and major laboratory instrumentation.
- Ability to interpret laboratory data and make sound compliance decisions based on such interpretations.
- Action oriented/drives for results • Excellent communication and interpersonal skills
- Ability to coach, mentor and teach • Excellent decision making, problem solving and analytical skills
- Change agent with the ability to influence at all levels of the organization
- Detail-oriented with the ability to work under tight deadlines • Ability to handle multiple priorities
- Excellent conflict management skills • Builds positive relationships with others
- Excellent time management skills
- Manages diversity
- 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 70 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.
Posted on 11th November 2019