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QA Specialist - 33587


🌟 Exciting Opportunity: Specialist QA (33587) 🌟

📍 Location: East of Puerto Rico

💼 Positions Available: 1

Duration: Approximately four months

🏢 Work Arrangement: 100% onsite, Administrative Shift


Summary

We are seeking a highly skilled Specialist QA to support our client's Quality Assurance program under minimal supervision. This is an exciting opportunity to contribute to the assurance of product quality in a dynamic environment. 🎉


Educational and Software Requirements

  • Education:
  • 🎓 Doctorate or Master’s degree with 3 years of directly related experience,
  • or Bachelor’s degree with 5 years of directly related experience in Sciences or Engineering.


Preferred Qualifications:

  • 🏆 Expertise in Quality Systems such as Deviations (Non-conformities), CAPA, and Change Control.
  • Experience in facilities, equipment, and utilities validation is required.
  • Hands-on experience with electronic systems, including:
  • 📄 Documentation platforms (CDOCS)
  • ⚙️ Maximo
  • 📊 Trackwise
  • 🧪 LIMS
  • 🛠️ Electronic Batch Record (MES)
  • 💻 SAP


Key Responsibilities

  • ✅ Review and approve product Master Plans (MPs).
  • 🔍 Approve process validation protocols and reports for manufacturing processes.
  • 🛡️ Participate as a Quality representative on the incident triage team.
  • 🌱 Approve Environmental Characterization reports.
  • 🚰 Release sanitary utility systems.
  • ✅ Approve planned incidents.
  • 🌟 Represent Quality Assurance on the New Product Introduction (NPI) team.
  • 🔍 Lead investigations and site audits.
  • 📚 Own site quality program procedures.
  • 👩‍⚕️ Act as a designee for the QA Manager on the local Clinical and Regulatory Board (CCRB).
  • ⚖️ Review Risk Assessments and support automation activities.
  • 🏭 Support facilities and environmental programs.
  • 📝 Review and approve Work Orders, EMS/BMS alarms, and Non-Conformance investigations and CAPA records.
  • 🔄 Approve change controls and provide lot disposition, authorizing lots for shipment.


Competencies & Skills

  • 📈 Strong project management and organizational skills, with the ability to follow assignments through to completion.
  • 💪 Enhanced skills in leading, influencing, and negotiating with a focus on collaboration and coordination with higher-level outside resources.
  • 🧠 Strong knowledge of manufacturing and distribution processes, including Quality Assurance (QA), Quality Assurance Laboratory (QAL), validation, and process development.
  • 🌐 Demonstrated ability to interact effectively with regulatory agencies.
  • 🖥️ Proficient in word processing, presentation, database, and spreadsheet applications.
  • ✍️ Excellent written and oral communication, facilitation, and presentation skills.
  • 🤝 Ability to work independently while effectively interacting with various levels within the organization.
  • 📊 Advanced data trending and evaluation skills with the ability to assess compliance issues.
  • 🌍 Fully bilingual in English and Spanish.


If you are a dedicated professional passionate about quality assurance and looking to make a significant impact in the pharmaceutical industry, we encourage you to apply today inside the job description with your updated resume! 🌱👏✨

Thank you. We will be in contact soon.

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