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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

Join our dynamic team where your skills make a difference! 🚀 #JobOpportunity #QA #ScienceCareers 🌐🔬

Thank you. We will be in contact soon.

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