job summary :
As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena.
Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions.
Focusing on immune diseases like HIV that affect a large percentage of the population, the work our longtime partner conducts is imperative to a better, healthier future.
To be recognized as a crucial part to furthering this goal, join this growing team now!
responsibilities :
- The technical writer position will require interaction with manufacturing personnel, manufacturing engineering managers, manufacturing compliance, Quality assurance and Manufacturing Science and Technology (MSAT) in order to develop and improve procedures and Master Batch Records (MBR’s) for using in producing vaccines at the 301 Binney Street location in Cambridge MA.
- The technical writer will coordinate with manufacturing and technical personnel to create and modify SOP’s and MBR’s, manage team meetings to obtain and resolve comments, escort documents through the review and approval process.
- Most technical input will be provided by company personnel but familiarity with GMP manufacturing, Good Documentation practices and significant figures is required.
- Familiarity with biologic manufacturing processes and equipment for downstream operations and familiarity with calculations typically used in the preparation of batch records for biological products is a plus.
- The technical writer will manage multiple documents revision requests and must have good organizations skills, and the ability to schedule and coordinate meetings and maintain a tracking spreadsheet.
qualifications : Requirements :
Requirements :
- 3+ years’ experience with MSWord, utilizing formatting.
- 2+ years of experience revising MBRS, SOP’s and managing document reviews and approval work flows.
- 2+ years of MS Excel
- Self-starter that can advance documents by working with other personnel without direct oversight by manager.
Preferences :
- Experience with managing workflows in Veeva
- Experience with SAP
skills :
SOP, MS-EXCEL, GMP (Good Manufacturing Practice)
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