Alphanumeric is hiring a FEV TECH WRITER to work out of Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements. The Tech Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the FEV (Facilities, Engineering and Validation) department, As well as revising and writing procedures, and acting as document coordinator.
Update, author and review FEV standard operating procedures and other controlled documents as a result of process improvements and CAPAs, Gap Assessments.
Perform investigation activities and writing deviation investigation reports for FEV departments.
Collaborate with SMEs from other departments to ensure a cross functional evaluation is completed and ensure alignment of GxP practices.
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.
Initiate Change Controls as required for Engineering/Facilities operations.
Manage Facilities Engineering GMP documents through lifecycle as document coordinator
Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. Established in 1979 we lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs. But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are!) Apply today to join our family and Make Your Mark!
Education and Experience:
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 for equipment related issues.
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.