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
To perform quality control analysis on radiopharmaceuticals for patient use and raw material testing in accordance with principles of Good Manufacturing Practice (GMP).
Essential Functions
Accurately perform Quality Control testing on all manufactured products on site according to MA, GMP and EP guidelines; use of gas chromatography (GC), TLC and HPLC
Manage the Environmental Monitoring process and ensure data is recorded and trended in the QMS
Reading Microbiological plates, bioburden and sterility samples
Interpretation and recording of Microbiological data and report any out-of-specification, ensuring appropriate action is taken in a timely manner
Review and maintain QC logbooks and data to ensure the site meets all its objectives in relation to data integrity policy
Perform and manage maintenance and calibration of lab equipment
Partake in validation activities, preparation and execution of protocols
Liaise with Quality Management on validation strategy and training
Checking stock level and ordering supplies
Endotoxin testing
Raw materials testing
Goods in check/inspection as part of quality inspections of incoming materials
Reviewing compliance of analytical methods with GMP/special guidelines and EP/USP
Ensure timely completion and update of all Quality records and trackers
Raising and completing deviation reports, OOS, and change controls where applicable
Participate in Root Cause Analysis and CAPA identification
Effective communication with all colleagues to facilitate efficiency in both production and quality-related matters
Maintain paper and electronic records from all QC processes for statutory purposes, including quality control under GMP
Comply with the requirements of the Pharmaceutical Good Manufacturing Practice (GMP), Ionising Radiation Local Rules, COSSH and Health & Safety procedure
Requirements
Level of professional and intellectual ability
Knowledge of Ionising Radiation Local Rules, COSSH and Health & Safety procedure (desirable)
Knowledge of working within a GMP environment
A willingness to work flexibly and commit to early working hours in a shift pattern.
Education/experience
Related Science Degree, i.e. analytical science, chemistry or related discipline
Working knowledge of pharmaceutical chemistry and good manufacturing practice is desirable
Experience in using QC equipment: GC, TLC, HPLC, and pH meter would be advantageous
Skills
Excellent team player
Able to work on own initiative
Practical ability
Stress handling
Excellent attention to detail
Full Driving licence (required)
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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