The Technical Writer will draft or assist with the creation of production process documentation, as related to the development of novel radioisotope processing systems. This documentation will be in the form of operator work instructions, batch production records and other associated production procedures. All associated documentation will be updated throughout the development, verification and validation processes, as related to systems used in the production of pharmaceutical products. This position also involves the development of production equipment service and maintenance procedures and manuals, which include calibration, preventative maintenance, troubleshooting and repair processes.
All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following (other duties may be assigned):
1. Draft production process documentation in the form of production operator work Instructions, batch production records and other production procedures.
2. Participate in the equipment qualification process, analyzing the use and performance of production equipment and translating this information into associated documentation. This may include collaborating with engineers, and/or working with the equipment to verify operation.
3. Assist with the development and implementation of NorthStar Medical Radioisotopes quality system processes and ensure compliance of applicable quality system regulations.
4. Assist with creation and management of NorthStar’s Equipment files including generation of work instructions, validations, assessments and other documentation as needed.
5. Compose standard operating procedures for manufacturing operations. This may include working with Operations, Engineering and others to establish needs, steps and desired processes.
6. Assist with the design of standards and procedures for general policy. This may include working with Engineering and management to develop best practice documents for internal operations.
7. Assist with the development of standards and procedures for general policy and documentation practices.
8. Work with outside vendors to collaborate on the creation of operational and service manuals for custom equipment and system designs.
9. Work with outside vendors, including engineers and operations personnel to create calibration, preventative maintenance, troubleshooting, and repair processes of production equipment.
10. Assist with the preparation of comprehensive training materials for production personnel.
11. Review, revise and/or standardize documentation written by others.
12. Work within change control and document management system to update documentation.
13. Follow good documentation practices.
14. Address and manage safety and quality issues raised by customers or staff in a timely fashion.
15. Support NorthStar’s Quality System and Health and Safety Program by following procedures.
Ability and willingness to travel both domestically and internationally up to 15% of the time.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor’s or Technical Degree in Engineering or Science and one to three years of experience in an FDA regulated environment; or equivalent combination of education and experience. Experience with authoring technical systems documentation, including manufacturing processes, within a medical device/pharmaceutical industry preferred.
Proficient knowledge of Microsoft Office software programs including Word, Excel, PowerPoint, and SharePoint. Knowledge of Adobe Suite programs such as Illustrator, PhotoShop, and FrameMaker preferred. Knowledge of video editing and SolidWorks software a plus.
• Excellent communication skills, verbal and written
• Strong decision making skills
• Strong problem solving skills
• Ability to handle multiple tasks simultaneously
• Ability to work in a fast-paced environment
• Ability to work in a team environment, as well as independently
• Adaptable to change in the work environment
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.