Validation Technical Writer

Framingham, Massachusetts
Industry: Technical Writer / Content writer
Job Number: JN -062021-65748

Description:

  • Seeking a highly motivated individual to perform review/QC of method validation study data and review/edit scientific and technical documents for compliance with quality management systems and regulatory guidelines (GLP / GCLP).
  • The candidate will work closely with scientists and technical staff to support review of study data and review and revision of method validation reports and nonclinical and clinical study reports.

Specific duties will include:

  • Perform detailed review of analytical test data and documentation to ensure data integrity.
  • Data compilation, table generation and review of data/tables for quality and consistency.
  • Review data and reports for compliance against standard operating procedures, method validation plans and GLP/GCLP regulations.
  • Assist with the editing of quality documents to ensure compliance with regulatory requirements.
  • This position is not remote, duties require candidate to be onsite most days.

SKILLS

  • Experience with data review/QC in a GLP/GCLP regulated setting
  • Exceptional attention to detail
  • Excellent organizational and time management skills
  • Ability to work collaboratively in a fast-paced team environment where multiple concurrent projects must be completed in a timely manner
  • Outstanding verbal and written communication skills
  • Proficiency in Microsoft Outlook, Word and Excel
  • Familiarity or experience with mass spectrometry and/or ligand binding assay analytical testing methodologies and equipment. 

Preferred:

  • Data review and technical writing/editing/review experience
  • Candidates with laboratory experience and a working knowledge of Watson LIMS

EDUCATION

  • Candidate must hold a bachelor’s degree from an accredited college or university in one of the chemical, physical or biological sciences with at least 3 years of experience working in a regulated laboratory (GxP).
Apply Online Apply Later