Posted on 30th January 2020
Quality Control Manager
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
The Quality Control Manager at the Maryland Heights facility is responsible for leading the Analytical Chemistry Department and the Radiation Physics Department (Day Shift, Night Shift and weekend operations). While managing in a cGMP environment, he/she must maintain operational compliance with U.S. and international regulatory agencies (i.e. FDA, NRC, BDB, DHSS, etc.).
The QC Manager will also oversee laboratory testing and provide resource and instrumentation allocation, conduct/review laboratory investigations, implements and monitors corrective actions. The QC Manager 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 Quality Control Manager participates in the hiring process, ensures training, and administers and monitors the job duties of analytical laboratory employees.
- While working in a cGMP environment, he/she must maintain operational compliance with U.S. and international regulatory agencies (i.e. FDA, NRC, BDB, DHSS, etc.) In addition, he/she must supply the highest level of both internal and external customer service.
- 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.
- 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 ALARA and manage their daily activities accordingly to ensure they meet their quarterly ALARA goals.
- Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member’s performance management.
- Measure and communicate team progress against individual, team and site goals and Key Performance Indicators (KPI’s).
- 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 of Science Degree in Chemistry, or other science related field, required.
- Minimum 5 years of experience in a cGMP environment.
- Minimum 3 years of leadership experience in a cGMP environment.
- Preferred Experience:
- Lean Leader/Operational Excellence/5S
- Laboratory Instrument qualification
- Method validation/transfer
- Must 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.
- Must be able to wear a variety of personal protective equipment.
- Able to work in a team-based environment across all functional groups.
- Close attention to detail required, must possess good hand-eye coordination.
- 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.
- Able to remain calm in emergency situations while directing other employees
- Ability to follow procedures and enforce compliance with procedures
- Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
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