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! 🌱👏✨