Job Description
Title: Supply Chain Technical Investigations Writer
Duration: 6 months Contract to Hire
Location: Philadelphia PA 19114-Onsite only
Pay Rate-$38.00/hr on W2
Shift: 8:00 am to 4:30 pm est
Position Description:
Deviation Management is a top priority for us in support of our Patient First mission, values, and culture, with a specific focus on robust root-cause investigations, and continuous process improvement. Unit Philadelphia has established a Deviation Management Excellence leadership and execution structure under Supply Chain.
Essential Functions: 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.
Specific Duties, Activities and Responsibilities:
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 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 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:
Education Requirements:
Bachelors 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
Knowledge and Skill Requirements:
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
Employment Type: Contractor
Job Tags
Contract work, For contractors, Interim role, Local area, Shift work,