Deviations Writer
4 weeks ago
Desired Skills/Experience
- Background in cGMP documentation and Technical Writing
- Experience in a pharmaceutical manufacturing environment
- Bachelor’s degree in science, related life science, or engineering field
- Ability to complete multiple simultaneous deliverables within established deadlines
- Self-starter, ability to learn new systems and work cross functionally
Responsibilities
One of our largest pharmaceutical clients is seeing a Deviations Writer to join their team. The role will be onsite in Durham 3 days a week, with 2 days a week remote. This is in support of one of the fastest growing drugs at the plant and is critical to the success of manufacturing at the site. This area has two duplicate large scale purification processes, a fermentation process, and a sterile supply area. Different systems will be in different phases of the tech transfer, from commissioning to manufacture of our first GMP batches. As mentioned below, it is supporting the Deviation Management, Change Control, and Technical Operations workstreams. Depending on the skills and experiences of the candidates, you can either be dedicated to one workstream or splitting their time between multiple workstreams. The successful candidate will be detail oriented, can complete multiple simultaneous deliverables with established deadlines, and an ability to pick up new systems and processes. This is an excellent opportunity for you to get your foot in the door from the start of production.
- Author Atypical Investigations to support vaccine manufacturing
- Develop and implement corrective and preventive actions
- Author Change Controls to assess vendor changes to raw materials and components
- Author technical protocols to support sampling, shipping, receiving, validation, manufacturing, or process development activities
- Attend and communicate progress at weekly Tier meetings
