ALLTECH CONSULTING SVC INC
Pharmaceutical Technical Investigator
ALLTECH CONSULTING SVC INC, Phila, Pennsylvania, United States, 19117
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:
Leads with Integrity and Respect.
Delivers Results.
Demonstrates Business Acumen.
Fosters Collaboration and Teamwork.
Champions Change.
Engages and Inspires.
Coaches and Develops.
PHYSICAL REQUIREMENTS:
Individual may be required to sit, 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).
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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:
Leads with Integrity and Respect.
Delivers Results.
Demonstrates Business Acumen.
Fosters Collaboration and Teamwork.
Champions Change.
Engages and Inspires.
Coaches and Develops.
PHYSICAL REQUIREMENTS:
Individual may be required to sit, 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).
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