Sterile Manufacturing Specialist
Listed on 2026-07-01
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Manufacturing / Production
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Quality Assurance - QA/QC
Data Analyst
Sterile Manufacturing Specialist
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Sterile Manufacturing Specialist. Position Type:
Contract Hybrid
Required:
Previous hands on experience in:
Sterile Fill Finish Manufacturing Facility. 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: 5 Why Fishbone 6M 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.
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