USA-Technical Writer I (Scientific)
Location: Framingham, MA
Name: Kranthi Kumar Sirigiri
Technical Writer I #21-03555
- 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.
- 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.
- Candidate must hold a bachelor’s degree from an accredited college or university in one of the chemical, physical or biological sciences
- Must have a minimum 3 years of experience working in a regulated laboratory (GxP).
- 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.
- Technical writing/editing experience**highly preferred
- Candidates with laboratory experience and a working knowledge of Watson LIMS**highly preferred.
- **This position is not remote, duties require candidate to be onsite most days.