Sterile Manufacturing Specialist

Job Description

Job Description

At-a-Glance:
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.

• Contract
• On-Site 

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:
• 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.