Pharmaceutical Technical Investigator
10381 Decatur Rd Philadelphia, PA 19114 US
Job Description
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).
Technical Investigations Writer
OVERVIEW:
Deviation Management is a top priority for Client in support of our Patient First mission, values, and culture, with a specific focus on robust root-cause investigations, and continuous process improvement. Client Philadelphia has 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 Whys, 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 24x7 operation, when needed, in order to get all information required for accurate investigations
EDUCATION REQUIREMENTS:
- Bachelors 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 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
**salary will be commensurate with experience**
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