Technical Investigator Writer

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

• Title: Technical Investigator Writer
• Location: Philadelphia, PA
• Industry: Pharmaceutical
• Hours: M-F 9am-5pm (onsite)
• Salary: $35.00 an hr. based on experience (Paid Weekly - Benefits Available)
• Employment Type: Long Term Contract

Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products.

Job Scope:

The Technical Investigator Writer is responsible for performing investigational activities for internal cGMP manufacturing deviations and external complaints. This also includes writing deviation and complaint investigation reports. Additionally, the Pharmaceutical Technical Investigator will utilize effective root cause analysis tools, such as 5-why analysis, fishbone diagrams, etc. and create the associated CAPAs.

Essential Functions:

• Perform thorough investigations of manufacturing non-conforming events and external complaints 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 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
• Adjust work hours across our 24x7 operation, when needed, in order to get all information required for accurate investigations

Minimum Requirements:

• 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

Knowledge/Skills Requirements:

• Must possess excellent investigative, documentation, technical writing, and proofreading skills
• We will identify candidates based on the following:
• Leads with Integrity and Respect
• Delivers Results
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops

EOE/ADA
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