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Specialist QA/ PR (Drug Substance) 32900
🌟 Job Opportunity: Specialist QA (Drug Substance) 32900 🌟
📍 Location: Juncos, Puerto Rico
🗓 Period: 1/16/2024 to 6/30/2024
🏢 Onsite Job with Non-Standard Shift
🚫 No Corp-to-Corp Contracts; Locals in Puerto Rico Only
🎓 Educational and Software Requirements:
- Doctorate degree or Master's degree with 3 years of related experience
- Bachelor's degree with 5 years of related experience
- Associate's degree with 10 years of related experience
- 🖥 Preferred Qualifications: Experience in batch record review, DAI process, and familiarity with PASx/MES application, MAXIMO, SAP, and LIMS.
🌐 Description:
🔬 Quality Professional with Manufacturing Process Audit and Batch Record Review Experience 🔍
🌈 Available for Non-Standard Shifts, Including Nights and Weekends
Duties and Responsibilities:
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Request Quality on the incident triage team.
- Approve Environmental Characterization reports.
- Release sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Lead site audits.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.
- Review Risk Assessments.
- Support Automation activities.
- Support facilities and environmental programs.
- Review and approve Work Orders.
- Review and approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
🌐 Competencies/Skills:
- Project management skills.
- Strong organizational skills.
- Initiate and lead cross-functional teams.
- Enhanced skills in leading, influencing, and negotiating.
- Strong knowledge in the area of expertise.
- Collaborate and coordinate with higher-level outside resources.
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development.
- Demonstrate ability to interact with regulatory agencies.
- Strong word processing, presentation, database, and spreadsheet application skills.
- Strong communication (both written and oral), facilitation, and presentation skills.
- Strong skill in working independently and effectively interacting with various levels.
- Advanced data trending and evaluation ability.
- Ability to evaluate compliance issues.
- Demonstrate the Client Values/Leadership Practices.
📧 Contact: Send your resume with the job title to Flor Lopez at flopez@proqualitynet.com
Join our dynamic team where your skills make a difference! 🚀 #JobOpportunity #QA #ScienceCareers 🌐🔬
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