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
- Initiate, revise, and approve manufacturing procedures. Serve as a document owner. 📑
- Assess process performance and implement solutions for process improvement opportunities. 🚀
- Provide troubleshooting support. 🔧
- Assist in generating training materials. 📚
Process Monitoring
- Support establishment of process monitoring parameters and control limits. 📊
- Provide support for timely execution of process monitoring reports. 🕒
Non-Conformance and CAPA
- Ensure timely triage of Non-conformances. ⏰
- Author investigation reports. 📝
- Execute corrective actions. ✅
- Manage NC/CAPA closure within established goals. 🎯
- Monitor and communicate incidents trends. 📈
- Review equipment/system Root Cause Analysis investigations. 🔍
Process Validation
- Assist in generating process validation protocols and reports. 📑
- Assist in the execution of process validation. 🔄
- Support collection and analysis of process validation data. 📊
Regulatory
- May participate in regulatory inspections. 🕵️♂️
New Product Introductions & Process or Equipment Modifications
- Participate in the NPI process. 🚀
- Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects. 🔄
Change Control
- Assist manufacturing change owner on CCRB packages impacting the process. 🔄
Projects and Initiatives
- 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 🌐✉️