Posted on 30th January 2020
Lab Technical Writer (Contractor)
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 core responsibilities for this position is to act as a technical liaison, oversee the installation and qualification of new instruments and software, and provide content in the execution of test protocols. This position will work in the Analytical Chemistry laboratories with focus on improving data integrity for the site. This position will work directly with vendors to complete instrument and software installations and qualifications, the creation/revision of Standard Operating Procedures and Standard Test Methods and ensuring employees receive adequate training on the new instruments and software.
Designs and implements validation protocols to provide a technically and economically sound basis for qualifying new analytical instruments and associated software (HPLC, GC, FTIR, ICP, etc.).
Provides technical counsel concerning the scientific content of methods, analytical testing of samples, evaluation and interpretation of laboratory results, and other QC related issues as required.
Authors Change Controls in Quality Management systems.
Reports progress of validation work and significance of the results. Assists laboratory personnel with the process of instrument repair and troubleshooting, qualification and validation, and provides knowledge transfer.
- Author and execute analytical method, and equipment/instrument IQ/OQ/PQ protocols
- Able to work independently and manage workload
- Manage and prioritize projects in an organized and structured manner
- Author Standard Operating Procedures for new instruments/software
- Create and On the Job training forms and assist in training QC personnel on new instrumentation/software
- Maintain current knowledge of federal and international regulations regarding analytical chemistry and cGMP’s and proactively champion validation and optimization initiatives to meet same
- Assist in maintaining QC records such as equipment/instrument drawings and specifications, protocol and validation records and reports, etc., as required to establish and maintain control of all processes, systems and equipment.
- Ensure that all activities are performed to support all assigned tasks confidently and consistently
- Perform all work in compliance with site safety and radiation protection guidelines
- BS in Chemistry or related field required
- Experience in writing SOPs, test methods and/or protocols required
- Minimum 5 years cGMP experience in a finished pharmaceutical manufacturing environment required
- Experience investigating exceptions and out of specifications preferred
- Experience with Chromeleon, Trackwise or other instrument/compliance software an advantage
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