Pharmaceutical Technical Investigator

Job Description

Job Description:

Technical Investigations Writer
OVERVIEW:
Deviation Management is a top priority for the Company in support of our Patient First mission, values, and culture, with a specific focus on robust root-cause investigations, and continuous process improvement. We have established a Deviation Management Excellence leadership and execution structure under Continuous Improvement, Technology and Engineering (CITE).

SUMMARY:
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.

RESPONSIBILITIES:
• 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.
• Adjust work hours across our 24×7 operation, when needed, in order to get all information required for accurate investigations.

EDUCATION 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.

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

PHYSICAL REQUIREMENTS:
• Individual may be required to site, stand, walk regularly.
• Occasionally lift 0-15 pounds.
• Be accessible to manufacturing floor and office staff and to use required office equipment.
• Specific vision requirements include reading written documents and frequent use of a computer monitor.

Work Environment: 60% cubical/desk, 40% dynamic environment (packaging, warehouse, etc.) Temp to hire. Hiring to be evaluated in 6 months to one year time.

Must have:
• Microsoft Word/Excel/Outlook, Experience in a GMP environment.
• Minimum of 5 years in a GMP regulated environment, Packaging or Quality preferred.
• Must have Minimum of 2 years of investigation, CAPA, or Quality Assurance related experience.
• Bachelor’s Degree required, preferably in Science or Business (e.g., Chemistry, Pharmacy, Engineering, Operations).