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Job Details

Technical Investigations Writer

Company name
RCM Technologies, Inc.

Location
Barceloneta, PR

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Profile

The Technical Investigations Writer is responsible for performing investigation activities and writing deviation investigation reports supporting non-conforming (process and procedural deviation) events.

Additionally, the Technical Investigations Writer will deploy effective root cause analysis tools, such as 5-why analysis, fishbone diagrams, etc. and create the associated CAPAs.

Perform thorough investigations of manufacturing non-conforming events that could include review of cGMP documents and historical review of the quality management system

Perform investigations using structured root cause analysis tools (fishbone, 5 Why's, etc.) and partner with team members to determine true” root cause

Participate in defining right” CAPA after investigation process is complete

Conduct personnel interviews of those individuals involved with the event

Write concise and accurate event investigation reports with the goal to be successful in the first pass through the quality review

Write interim reports and extensions for investigations that exceed 30 days

Bachelor's Degree required, preferably in Science or Business (e.g., Chemistry, Pharmacy, Engineering, Operations)

Minimum of 2 - 5 years of CAPA, investigations, or manufacturing quality assurance experience

Minimum of 5 years manufacturing/technical experience in a regulated GMP environment; pharmaceutical industry preferred

Must possess excellent investigative, documentation, technical writing, and proofreading skills

Company info

RCM Technologies, Inc.
Website : http://www.rcmt.com/

Company Profile
RCM’s mission is to be in a leadership position in its industry by providing responsive, high-quality, reliable, technologically advanced, and cost-effective services that enable its customers to meet their business objectives, allow RCM to enhance shareholder value, and afford its employees the opportunity to realize their professional and personal goals. RCM supports this mission with dedication, resources and expertise.

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