“This company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and PuertRictbe vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations tstaff augmentation external workers whqualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship tthis company, its operations, or its staff.”
Top 3 Must Have Skill Sets:
Day to Day Responsibilities:
- GMP experience
- Technical writing experience
- Development of regulated or process documents with the ability to deliver high quality documentation
- Support of manufacturing operations
- Management of Manufacturing process documentation per required process in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
- Initiating and owning quality records
Working on site with the opportunity to work remotely in some instances.
This Company is the world’s leading biotechnology company. Nurtured on a foundation of strong values, This company is deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses. Our mission is to serve patients, and we encompass this with each initiative, goal and task we have in mind!
Operations is one of three foundational functions at this company with a mission to manufacture and deliver safe and effective medicine to patients around the world. The Operations Program at our Rhode Island site is divided into five functions: Supply Chain, Process Development, Quality, Manufacturing, and Facilities & Engineering.
We are currently seeking highly motivated, hardworking individuals who will directly support Manufacturing operations in our newest Next Generation Biomanufacturing plant. Along with key business partners and functional groups, this position will focus on directly supporting manufacturing operations and new product introductions.
The primary responsibilities for this role may include, but are not limited to the following:
Support of manufacturing operations
Management of Manufacturing process documentation per required process in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
Initiating and owning quality records (e.g. change controls, deviations, CAPAs)
Bachelor’s degree in Engineering, Science or related field
"This posting is for Contingent Worker, not an FTE"
- 3 or more years of experience in Cell Culture or Purification execution and/or support
- Single use technology experience
- Proficient on Microsoft Office Suite
- Ability to work independently and as a team player
- Excellent collaboration and problem solving skills
- Ability to work virtually
- Ability to understand, apply and evaluate basic chemistry, biology and physical principles
- Experience with Manufacturing execution and automation systems
- Experience with lab equipment/testing
- Experience in influencing and negotiation