Specialist Manufacturing-33488

🌟 Job Opportunity: Specialist Manufacturing 33488 🌟

📍 Location: Juncos, PR

⏰ Shift: 8:00 AM to 5:00 PM (Administrative Shift)

💼 Position: 1

🏢 Work Type: 100% Onsite

📅 Duration: Approximately 1 year

SUMMARY

With minimal supervision, this role supports the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. You’ll apply your process, operational, and scientific expertise, along with basic compliance knowledge, to provide analytical and troubleshooting support for manufacturing operations. 🌟 You may serve as the primary production process owner and assist with more complex process systems.

🎯 Preferred Qualifications

• 📑 Documentation: Procedure Revision
• 🛠️ QMTS Trackwise
• ✅ CAPA’s
• 🏭 Manufacturing Process
• 📋 Audits
• 🔬 Laboratory Knowledge

📝 KEY RESPONSIBILITIES

🛠️ Applied Process Expertise

• ✍️ Initiate, revise, and approve manufacturing procedures, ensuring all are up-to-date. Serve as a document owner.
• 📊 Assess process performance by observing floor operations and reviewing performance data. Identify and implement process improvement opportunities.
• 🛠️ Provide troubleshooting support.
• 🎓 Assist in creating training materials and may help deliver training on the scientific or technical aspects of processes.

📊 Process Monitoring

• 🚥 Support the establishment of process monitoring parameters and control limits. Collect and assess process-monitoring data and deviations.
• 🕒 Contribute to the timely execution of quarterly process monitoring reports.

⚠️ Non-Conformance & CAPA

• ⏱️ Ensure that all non-conformances are triaged within the established time goals.
• 📝 Author investigation reports and execute corrective actions.
• ✅ Manage non-conformance/CAPA closure within established timelines and monitor incident trends.
• 🔍 Review equipment/system Root Cause Analysis investigations and support trend evaluations.

✅ Process Validation

• 📑 Assist in generating process validation protocols and reports, as well as executing process validation tasks.
• 📊 Support the collection and analysis of process validation data.

📋 Regulatory

• 👩‍⚖️ Participate in regulatory inspections as needed.

🚀 New Product Introductions & Equipment Modifications

• 🛠️ Participate in the NPI process, assessing documentation, materials, training, and equipment modification requirements.
• 📈 Provide project management and implementation support for process or equipment modification projects.

🔄 Change Control

• 🔄 Assist in managing change control packages that impact the process.

📈 Projects and Initiatives

• 🔍 Participate in the assessment and implementation of special projects or initiatives.
• Additional duties may be assigned.

🎓 EDUCATION & EXPERIENCE REQUIREMENTS

• 🎓 Doctorate Degree OR
• 🎓 Master’s Degree with 3 years of Manufacturing Operations experience OR
• 🎓 Bachelor’s Degree with 5 years of Manufacturing Operations experience OR
• 🎓 Associate’s Degree with 10 years of Manufacturing Operations experience OR
• 🎓 High School Diploma / GED with 12 years of Manufacturing Operations experience.

🧠 CORE COMPETENCIES & SKILLS

• ⚙️ In-depth technical understanding of bioprocessing unit operations.
• ✅ Proficient in GMP production operations.
• 📋 Familiarity with regulatory knowledge and processes.
• 👥 Ability to participate and help lead cross-functional teams.
• 💬 Strong communication and collaboration skills with technical and management staff across manufacturing, process development, and quality departments.
• 🗂️ Excellent organizational, technical writing, and presentation skills.
• 📊 Basic project management skills.
• 📈 Working knowledge of control charting.

📧 Ready to make a difference?

🌟 Send your updated resume to careers@proqualitynet.com with the subject line: Specialist Manufacturing 33488. We can’t wait to see how your skills will contribute to the success of our client’s projects! 🚀