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Qa Specialist 33381 - 2391746

🌟 Join Our Team as a Title Specialist QA 33381 (Drug Substance)! 🌟

📍 Location: Juncos, PR

🏢 Work Type: 100% Onsite

🕒 Shift: 12-hour shifts, including weekends (AM and PM)

👥 Positions Available: 1


We are seeking a dedicated Specialist QA to join our client’s team in Juncos, PR. This role is crucial for ensuring the Quality and Compliance of our Drug Substance Manufacturing Processes. If you are passionate about quality assurance and have a keen eye for detail, we want to hear from you! 💼✨


  • ✅ Perform review, approval, and tracking of cGMP processes, procedures, testing, documents, and records, including batch record review, MES, EBR, SAP, and Trackwise.
  • 🚀 Engage in continuous improvement initiatives, programs, and projects.
  • 🔍 Ensure changes impacting product quality are assessed and comply with established procedures.
  • 📝 Certify MES/EBR change control and new implementations meet procedural and specification standards.
  • 📋 Verify production records and validation process results for accuracy and documentation compliance with cGMP regulations.
  • 🤝 Collaborate cross-functionally to execute Quality Management System processes per established procedures.
  • 🧩 Advise senior management on quality, compliance, supply, and safety risks.
  • 📣 Maintain communication with management on project progress through work center teams, daily meetings, and quality systems forums.
  • 🔧 Support internal and external audits and inspections, acting as the Quality unit representative as needed.
  • 📚 Ensure adherence to training requirements for task execution.
  • 💡 Champion and lead continuous improvement initiatives and projects.
  • 💻 Provide support and quality oversight for Digital MES automated teams.
  • 🏆 Demonstrate expertise in Quality Systems, including Non-Conformance, CAPA, and Change Control.
  • 🖥 Exhibit proficiency in computer systems validation and quality assurance.
  • 📂 Showcase strong organizational skills and the ability to follow assignments through to completion.
  • 🗣 Lead and influence cross-functional teams, negotiate effectively, and interact with regulatory agencies.
  • 📊 Utilize advanced word processing, presentation, database, and spreadsheet applications.
  • 📝 Communicate effectively in Spanish and English, both written and oral.
  • 🧑‍💼 Independently handle responsibilities and interact effectively with all organizational levels.
  • 📈 Trend and evaluate data to assess compliance issues.


  • 📄 Review and approve product MPs.
  • 🏭 Approve process validation protocols and reports for manufacturing processes.
  • 🚨 Participate in Quality incident triage teams.
  • 🌱 Approve Environmental Characterization reports.
  • 🔧 Oversee the release of sanitary utility systems.
  • ✅ Approve planned incidents.
  • 📊 Represent QA on the NPI team.
  • 🕵️ Lead investigations and site audits.
  • 📜 Own site quality program procedures.
  • 👥 Serve as designee for QA manager on local CCRB.
  • ⚖️ Review Risk Assessments.
  • 🤖 Support automation activities, facilities, and environmental programs.
  • 🛠 Review and approve Work Orders and EMS/BMS alarms.
  • 🔍 Approve NC investigations, CAPA records, and change controls.
  • 🚚 Provide lot disposition and authorize lots for shipment.

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:

  • 🗂 Strong project management and organizational skills.
  • 🤝 Ability to initiate and lead cross-functional teams.
  • 🏭 Expertise in manufacturing, distribution, QA, QAL, validation, and process development.
  • 🧑‍💼 Proficient in interacting with regulatory agencies.
  • 💻 Strong word processing, presentation, database, and spreadsheet application skills.
  • 🗣 Excellent communication, facilitation, and presentation skills in Spanish and English.
  • 🧑‍💼 Capability to work independently and interact with various levels of the organization.
  • 📈 Advanced skills in data trending, evaluation, and compliance issue assessment.
  • 📜 Adherence to our client's Values and Leadership Practices.

Why Join Us? This is a fantastic opportunity to advance your career in Quality Assurance and make a significant impact on the quality of life of patients. If you are ready to take on this challenge, send your updated resume to with the subject line: Title Specialist QA 33381 (Drug Substance).

We look forward to welcoming you to our team! 💼✨

Thank you. We will be in contact soon.

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