Manufacturing Specialist 33235 - 2057700

Title: Specialist Manufacturing 33235 (Pharma/Biotech Industry) 🏭🌟

Location: Juncos, PR 🌴

100% Onsite Work ⏰

Shift: 8:00am - 5:30pm, weekend support may be required (not regular shift) 🔄

Positions Requested: 1 💼

Period: Approximately one (1) year ⏳

Educational/Software Requirements:

• Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience OR Associate’s degree and 10 years of Manufacturing Operations experience OR High school diploma / GED and 12 years of Manufacturing Operations experience 📚

Preferred Qualifications: 🛠️📝

• Procedure development
• Change Control
• CAPA
• Deviation Investigations
• Risk Assessment

SUMMARY

Support the execution of manufacturing/quality systems with minimal supervision. Apply process expertise, compliance knowledge, and analytical skills to support operations.

FUNCTIONS

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures.
• Assess process performance and implement improvements.
• Provide troubleshooting support and training. 🛠️📚

Process Monitoring

• Support establishment of process monitoring parameters.
• Collect and analyze process-monitoring data. 📊

Non-Conformance and CAPA

• Triaging non-conformances and authoring investigation reports.
• Executing corrective actions and managing closure. 🔍🔧

Process Validation

• Assist with generation and execution of process validation protocols. 🧪

Regulatory

• Participate in regulatory inspections. 🏛️

New Product Introductions & Process/Equipment Modifications

• Participate in NPI process and assess requirements.
• Provide implementation support for process/equipment modifications. 🚀

Change Control

• Assist with manufacturing change control packages. 🔄

Projects and Initiatives

• Participate in special projects or initiatives. 🌟

COMPETENCIES/SKILLS

• Technical understanding of bioprocessing unit operations.
• Skilled in GMP production operations.
• Regulatory knowledge.
• Cross-functional team collaboration.
• Communication and presentation skills.
• Project management basics.
• Control charting knowledge. 📊

If you are interested in this exciting opportunity, please send your updated resume to careers@proqualitynet.com with the subject line "Specialist Manufacturing 33235" or simply apply through the job description. Join us in making a difference in the Pharma/Biotech Industry! 🚀💼