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Technical Writer (cGMP – Pharmaceutical) JD817648

JD817648

DPS Engineering is looking for capable Technical Writers to work with multiple BioPharma clients in the MA and NH areas. This individual will provide edits to cGMP documents while developing understanding of documentation and manufacturing processes.

Category:
Miscellaneous Personnel
Location:
Massachusetts
Years of Experience Req.:
2+
Date Posted:
15/02/2019
Days Remaining:
12
Employment Type:
Full-time
Education Level Req.:
Bachelors Preferred

Technical Writer (cGMP – Pharmaceutical)                JD817648

MA and NH areas

 

Summary:

 

DPS Engineering is looking for capable Technical Writers to work with multiple BioPharma clients in the MA and NH areas. This individual will provide edits to cGMP documents while developing understanding of documentation and manufacturing processes.

 

Core Responsibilities:

  • Responsible for the review and editing of documents pertaining to buffers and media, early cell development, and cell quality and purification.
  • Create new cGMP documents with assistance from within the department.
  • Manage document comments in order to answer and translate questions into the reviewed document to meet regulatory, internal, and external requirements.
  • Perform initial review for scope, attain sign-offs and justifications, set up review meetings, etc.
  • Must be able to extract and coordinate information from multiple sources and consolidate material into technical documentation.
  • Maintain files and logs in a GMP state.

 

Education and Qualifications:

  • Bachelor’s degree in Engineering or Sciences is preferred.
  • Previous experience working within a GMP manufacturing environment.
  • Demonstrated document editing and proofreading experience.
  • Knowledge of cGMP and manufacturing process knowledge is required.
  • Must understand how CAPAs (corrective actions/preventative actions) and change controls must be incorporated into a document.
  • Strong written and oral communication skills
  • Highly organiz134167.666161ed with effective time management (ensuring completion of work tasks)
  • Strong attention to detail.
  • Ability to work well cross-functionally with various people and groups.
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