Quality Investigator Apply
Please find the job details and description below and if interested You can reach me at or call me at +1(732)-813-9025.
Role: Quality Investigator
Location: Rocky Mount, NC Onsite
Duration: 12 Months
Role: Quality Investigator
Location: Rocky Mount, NC Onsite
Duration: 12 Months
Day to day:
- Sustain and improve processes for filling in a cleanroom environment.
- Aseptic gowning qualified.
- Interface with equipment engineering, management, and manufacturing to improve cycle time, tool availability, process/product yield, and drive cost reductions.
- Perform tool maintenance to address process issues.
- Create and maintain operating specifications for production processes that run through the Filling Lines.
- Lead or support major equipment related investigations and implement equipment corrective or preventative action and performance improvements via Change Control process.
- Risk/Impact Assessments (PFMEA).
- Experience with Optima Washers, Tunnels, CIP/SIP Skid, and Filler equipment.
- Experience with Genesis Capper equipment.
- Organize testing associated with the development of new process technologies and the support of new product introductions and tech transfers.
- Create and execute engineering notebook studies/protocols.
- Ensure integrity and compliance of data according to Standard Operating Procedures.
- Coordinate all work on scheduled projects (personnel activities, documentation and outside resources).
Must have requirements:
- 3-5 years of experience in a GMP/Pharma manufacturing environment
- Prior experience utilizing various investigation tools (5 Whys, Fishbone, 6 Ms, DMAIC method, etc.)
- Prior experience with technical writing (such as deviations, etc.)
- Proficiency with MS Office Suite (specifically Word, Excel, and PowerPoint)
- Strong written and verbal communication skills; ability to effectively communicate with employees at all levels within the organization, including plant colleagues and senior management.
- Excellent facilitation skills and ability to facilitate strategy meetings.
- Ability to effectively organize data, extract key information, and write technical summary report