QA Specialist - 33629

🌟 Title: QA Specialist 33629 🌟

📍 Location: East of Puerto Rico

📅 Shift: Administrative

💼 100% Onsite Opportunity

⏳ Duration: Approximately five months

🧑‍🤝‍🧑 Positions: 1

🔎 Summary:

Join our client’s Quality Assurance program and perform crucial QA duties with minimal supervision. We're looking for a skilled professional with strong attention to detail and leadership abilities.

📚 Educational & Software Requirements:

• Doctorate degree OR Master's degree with 3 years of directly related experience
• Bachelor's degree with 5 years of directly related experience
• Associate's degree with 10 years of directly related experience
• High school diploma/GED with 12 years of directly related experience

Preferred Qualifications:

• Educational background in Life Science and/or Engineering
• Fully bilingual in English and Spanish
• Strong Microsoft Office and presentation skills

✨ Key Responsibilities:

• Perform Trackwise system queries and manage deviations 🖥️

• Participate in the triage process 🔍

• Oversee GMP tasks to ensure process adherence 🧪

• Manage Change Controls and deviations as the QA contact

• Collaborate with operations to resolve compliance discrepancies 🛠️

• Knowledge in Validations and Laboratory equipment 🔬

• Review and approve product MPs

• Approve Environmental Characterization reports 🌍

• Approve planned incidents 🚦

• Provide lot disposition and authorize lots for shipment 📦

🌟 Competencies & Skills:

• Project management skills – Lead cross-functional teams and complete assignments 💼
• Organizational skills – Strong ability to follow through on assignments 📋
• Leadership – Influence, negotiate, and interact effectively at all levels
• Regulatory knowledge – Demonstrate interaction with regulatory agencies
• Problem-solving – Tackle compliance issues and provide effective solutions

🔧 Additional Functions:

• Lead site audits and investigations 🔍
• Represent QA on the NPI team
• Review and approve Work Orders, NC investigations, CAPA records, and more
• Support automation activities and facilities programs
• Own site quality program procedures 🏭

🏆 Be a part of a collaborative, dynamic team that values quality and leadership!