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Technical Investigation Writer I

System One
Philadelphia, PA
  • Expired: September 28, 2022. Applications are no longer accepted.

Title: Technical Investigation Writer I Location: Philadelphia, PA Schedule: Mon-Fri, 8:00am-4:30pm Type: Contract to hire Start date: ASAP

Responsibilities:

+ Performing investigation activities and writing deviation investigation reports supporting non-conforming (process and procedural deviation) events.

+ Deploy effective root cause analysis tools, such as 5-why analysis, fishbone diagrams, etc. and create the associated CA Strong written and verbal communication skills

+ Able to multi-task and collaborate in groups for resolution Investigation skills and CAPA development PAs.

+ Supply Chain Technical Investigations Writer Deviation Management is a top priority for Catalent in support of our Patient First mission, values, and culture, with a specific focus on robust root-cause investigations, and continuous process improvement.

+ Perform thorough investigations of Supply Chain non-conforming events and customer 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 or customer complaint

+ 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, to get all information required for accurate investigations

+ Generate trend analysis reports of historical investigation on an as needed basis.

+ Partner with local and global teams on required process and system enhancements.

+ Support client communications both written and oral with investigation follow ups

Requirements:

+ Bachelor's Degree preferred, 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

+ 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

+ 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

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

System One, and its subsidiaries including Joule, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

System One

Address

Philadelphia, PA
19133 USA

Industry

Education

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