Job Description
Hello,
Greetings of the day.
This is Vydehi from Intellectt Inc. We currently have an opening for a Quality Investigator with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to vydehi@intellectt.com or reach out to me directly at +1 732 355 7412
Job Title: Quality Investigator
Location: Rockymount, NC
Duration: Long time
Job Summary We are looking for a Quality Investigator to support and improve sterile filling processes in a cleanroom environment. This role focuses on leading equipment investigations, conducting risk assessments, and collaborating with various teams to optimize processes and ensure GMP compliance.
Key Responsibilities - Process Improvement : Enhance sterile filling operations and ensure compliance with cleanroom standards.
- Equipment Support : Work with engineering and manufacturing teams to improve cycle times, tool availability, and product yield while reducing costs.
- Tool Maintenance : Address and resolve equipment-related process issues.
- Documentation : Create and update operating procedures for production processes.
- Investigations : Lead equipment investigations and implement corrective actions using Change Control.
- Risk Assessment : Conduct Risk/Impact Assessments (PFMEA) to identify and mitigate process risks.
- Equipment Expertise : Hands-on work with Optima Washers, CIP/SIP systems, and Genesis Capper.
- Project Coordination : Support new product development, tech transfers, and testing for new processes.
Requirements - Experience : 3-5 years in a GMP pharmaceutical manufacturing environment.
- Problem-Solving : Experience with investigation tools like 5 Whys, Fishbone Analysis, and DMAIC.
- Technical Writing : Strong skills in writing reports, deviations, and SOPs.
- Software Skills : Proficient in MS Office (Word, Excel, PowerPoint).
- Communication : Excellent written and verbal skills, able to work with all levels of the organization.
Preferred Skills - Experience with aseptic gowning and working in cleanrooms.
- Hands-on knowledge of filling line equipment and processes.
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