Technical Writer job in Cambridge, USA

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Job type: Contract

Discipline: Medical Communications, Medical Writing, Media & Publishing

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Technical Writer for a global biopharmaceutical company located in Cambridge, MA.

The Tech Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the Engineering, Facilities and Validation department, As well as revising and writing procedures, and acting as document coordinator.

Must be eligible to work in the US.

Job Responsibilities:

Perform investigation activities and writing deviation investigation reports for Engineering, Facilities, and Validation department.
Coordinate prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.
Write concise and accurate investigation reports.
Utilize various root cause analysis, analytical and problem-solving tools to determine root cause of GxP deviations and assist with the completion of impact analysis and identification of appropriate corrective actions to prevent recurrence.
Participate in determining the appropriate corrective and preventative actions (CAPAs) after the investigation process.
Update, author and review standard operating procedures and other controlled documents as a result of process improvements and CAPAs, Gap Assessments.
Initiate Change Controls as required for Engineering/Facilities operations.
Collaborate with SMEs from other departments to ensure a cross functional evaluation is completed and ensure alignment of GxP practices.
Manage Facilities Engineering GMP documents through lifecycle as document coordinator

Skills and Requirements:

Requires a bachelor's degree, preferably in a scientific/engineering discipline, with a minimum of 3-5 years of experience in a pharmaceutical or related industry.
Demonstrate a sound understanding of cGMP's, FDA regulations, and pharmaceutical manufacturing/packaging processes.
Minimum of 3 years technical experience in a regulated GxP environment.
Experience in troubleshooting, investigation, and root-cause/analytical/problem-solving capabilities in a GxP environment.
Demonstrated, strong technical writing skills with the ability to read, comprehend, and communicate complex, technical events in a manner that is concise, clear, and accurate.
Demonstrated ability to work independently and as part of a collaborative, cross-functional team.
Working knowledge of TrackWise, SAP or similar deviation management system, and Veeva or similar quality document system.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at +(1) 267-846-2026 or j.cerchio@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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