Manufacturing Specialist - 33654
🌟 Job Opportunity: Specialist Manufacturing 33654 🌟
📍 Location: East of Puerto Rico Island (Hybrid on administrative shift)
🕒 Period: Approximately 1 year
👥 Positions Available: 1
✨ Summary of Role
With minimal supervision, you’ll support the execution of critical manufacturing and quality systems, such as non-conformances, process validation, procedures, training, and new product introductions. This role requires strong analytical, troubleshooting, and compliance skills to support manufacturing operations. You may serve as a primary production process owner and assist with more complex process systems.
🎓 Qualifications
- Doctorate degree OR
- Master’s degree with 3 years in Manufacturing Operations OR
- Bachelor’s degree with 5 years in Manufacturing Operations OR
- Associate’s degree with 10 years in Manufacturing Operations OR
- High school diploma/GED with 12 years in Manufacturing Operations
Additional Skills Needed:
- Background: Quality or Engineering
- Project Management: Skilled at coordinating cross-functional teams and meeting project deadlines
🌐 Preferred Skills
- Quality Records Management: Experience with Deviations, CAPAs, and Change Controls using TrackWise or Veeva Systems
- SAP ERP Experience: Skilled in navigating SAP
- Communication Skills: Strong technical writing and presentation skills
- Analytical Abilities: Ability to work independently, present data logically, and manage priorities effectively
- Negotiation: Proven ability to negotiate with suppliers and internal teams
📋 Core Responsibilities
🛠 Applied Process Expertise
- Revise and approve manufacturing procedures, ensuring all documents reflect current operations
- Assess and improve process performance through floor observation and data review
- Provide troubleshooting and support for process improvement opportunities
- Assist in training material generation and delivery
📊 Process Monitoring
- Support the establishment of process control limits
- Collect monitoring data and assist with deviation assessments
- Support timely completion of quarterly process monitoring reports
⚠️ Non-Conformance and CAPA
- Triage and author investigation reports
- Execute corrective actions and manage closure within established timelines
- Monitor trends and communicate incident patterns
- Conduct root cause analysis for equipment and system investigations
📏 Process Validation
- Assist in protocol/report generation and data collection
- Support process validation execution and data analysis
📝 Regulatory
- Participate in regulatory inspections, providing relevant expertise
🆕 New Product Introductions & Equipment Modifications
- Assess and support NPI requirements: documentation, materials, training, and equipment updates
- Prioritize and manage process/equipment modification projects
🔄 Change Control
- Assist as manufacturing change owner for CCRB packages impacting processes
🌐 Projects and Initiatives
- Participate in special projects and initiative assessments
Note: Additional functions may be assigned as needed.
🌟 Competencies/Skills
- Bioprocessing Knowledge: Strong technical understanding of bioprocessing
- GMP Production: Skilled in GMP operations
- Regulatory Knowledge: Experienced with regulatory requirements and inspections
- Team Collaboration: Ability to effectively work in cross-functional teams
- Project Management: Basic project management skills
- Data Analysis: Basic knowledge of control charting for process improvement
📌 Ready to Apply?
If you’re looking for a dynamic and impactful role with our client by contract with ProQuality Network, apply now inside the job description link and join us in driving manufacturing excellence! For additional roles, follow us on LinkedIn and explore our website. 🌐