Technical Writer I in Framingham, MA at Integrated Resources, Inc

Date Posted: 5/14/2021

Job Snapshot

Job 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 aProductst 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:
Technical writing/editing experience
Candidates with laboratory experience and a working knowledge of Watson LIMS
EDUCATION
Candidate must hold a bachelors 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).