MSAT Documentation Scientist II
Thermo Fisher Scientific · Greenville, NC · 2 days ago
On-siteResearchFull-time
Responsibilities
- Author and improve procedures including SOPs, Batch Records, Protocols, training documents, etc.
- Author Change Controls, in electronic Quality Management System and Document Management System.
- Lead cross-functional investigation teams in CAPA closure.
- Presents recommendations internally.
- Leads assignments, including managing project timelines and deliverables.
- Liaises with internal Quality, Operations, Engineering, Validation, and other functional areas to meet team objectives.
- Guides and advises documentation and training strategies during implementation of new methodologies and processes.
- Maintains the necessary compliance status required by company and facility standards.
Requirements
- Bachelor of Science in any Science or STEM degree preferred.
- Associate degree is preferred.
- Other Education and time in industry can be considered.
- 0-2 years of progressive scientific experience and/or coursework.
- 2-4 years of scientific experience (preferred), preferably in the pharmaceutical industry.
- Experience with technical writing is a plus.
- Education and time in the industry can be considered.
- Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.
Qualifications
- Thorough knowledge of Good Manufacturing Practices.
- Strong proficiency in Microsoft Office Suite (including Word, Excel, and PowerPoint).
- Excellent critical and logical thinking skills.
- Effective written, interpersonal, and presentation skills, including managing technical discussions with internal and external clients.
- Ability to work on multiple projects simultaneously.
- Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
- Ability to keep current with scientific literature and industry trends relating to process technologies.
- Ability to develop technical solutions.