Manufacturing Specialist 33080 - 1837105

🌟 Job Opportunity: Specialist Manufacturing 33080 🌐

📍 Location: Juncos, PR (Onshore, 100% Onsite work, 8-hour administrative shifts) 🌅

📑 Period: Approximately One Year by contract.

👩‍🎓👨‍🎓 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:

Experience in Manufacturing, Procedures Revision, Change Control, CAPA’s, Investigation process, Deviations, Risk assessment, Problem Solving, Technical Writing, and Process ownership.

SUMMARY:

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.

FUNCTIONS:

Applied Process Expertise

1. Initiate, revise, and approve manufacturing procedures. Serve as a document owner. 📑
2. Assess process performance and implement solutions for process improvement opportunities. 🚀
3. Provide troubleshooting support. 🔧
4. Assist in generating training materials. 📚

Process Monitoring

1. Support establishment of process monitoring parameters and control limits. 📊
2. Provide support for timely execution of process monitoring reports. 🕒

Non-Conformance and CAPA

1. Ensure timely triage of Non-conformances. ⏰
2. Author investigation reports. 📝
3. Execute corrective actions. ✅
4. Manage NC/CAPA closure within established goals. 🎯
5. Monitor and communicate incidents trends. 📈
6. Review equipment/system Root Cause Analysis investigations. 🔍

Process Validation

1. Assist in generating process validation protocols and reports. 📑
2. Assist in the execution of process validation. 🔄
3. Support collection and analysis of process validation data. 📊

Regulatory

1. May participate in regulatory inspections. 🕵️‍♂️

New Product Introductions & Process or Equipment Modifications

1. Participate in the NPI process. 🚀
2. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects. 🔄

Change Control

1. Assist manufacturing change owner on CCRB packages impacting the process. 🔄

Projects and Initiatives

1. Participate in the assessment or implementation of special projects or initiatives. 🚀

COMPETENCIES/SKILLS

• Detailed technical understanding of bioprocessing unit operations. 🧪
• Skilled in GMP production operations. ⚙️
• Regulatory knowledge. 📚
• Cross-functional team leadership. 👥
• Effective communication and collaboration. 🗣️
• Organizational, technical writing, and presentation skills. 📊
• Basic project management skills. 🚀
• Basic knowledge of control charting. 📈

Apply now and be a key player in shaping the future of biotech manufacturing! 🚀🌟

📧 Send your updated resume along with the title Specialist Manufacturing 33080 to careers@proqualitynet.com 🌐✉️