Analysis Skills, Asepsis, Chemistry, Consulting, Corporate Compliance, Corrective and Preventative Action (CAPA) Systems, GMP (Good Manufacturing Practices), Identify Issues, Investigative Reports, Laboratory, Machining, Manufacturing, Manufacturing Engineering, Manufacturing/Industrial Processes, Quality Assurance, Quality Control, Root Cause Analysis, Technical Writing, Writing Skills
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring an API Manufacturing Engineer.
Position Type:Required:- Previous hands on experience in: API Manufacturing.
- Experience performing deviation investigations in GMP environments.
- Shop floor manufacturing experience.
- Strong root cause analysis and investigation skills.
- Good technical writing/documentation skills.
- Experience with CAPA activities.
- Experience supporting manufacturing/process troubleshooting.
Nice to Have:- Quality Operations experience.
- QC chemistry lab experience.
- Aseptic manufacturing experience.
- Batch investigation experience.
- Backlog investigation remediation experience.
Responsibilities:
Main Responsibilities:- Lead deviation investigations from initiation to closure.
- Perform root cause analysis using tools such as:
o 5 Why
o Fishbone
o 6M
o Cause & Effect Analysis
- Write clear and well documented investigation reports.
- Support CAPA definition, implementation and effectiveness checks.
- Support backlog investigation remediation activities.
- Work closely with Manufacturing, QA, QC and technical teams during investigations.
- Update SOPs and GMP documentation when required.
Get in Touch:
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Vaibhav at 551-227-9117 to learn more.
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Hired by Matrix
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