Manufacturing Process Auditor

hace 7 días


Juncos, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

About Us

Biopharma Consulting Jad Group is a leading provider of quality assurance services to the pharmaceutical industry. We are committed to delivering high-quality products and services that meet the needs of our clients.

Job Summary

The Quality Assurance Specialist will be responsible for supporting our Quality Assurance program with minimal supervision. The ideal candidate will have experience in manufacturing process audits, batch record review, and quality compliance.

Key Responsibilities:

  • Review and approve product manufacturing procedures (MPs).
  • Approve process validation protocols and reports for manufacturing processes.
  • Serve as Quality representative on incident triage teams.
  • Approve Environmental Characterization reports and sanitary utility system releases.
  • Review and approve: Planned incidents Work orders EMS/BMS alarms Non-conformance (NC) investigations and CAPA records Change controls Provide lot disposition and authorize lots for shipment.
  • Represent QA on New Product Introduction (NPI) teams.
  • Lead investigations and site audits to ensure compliance.
  • Own and maintain site quality program procedures.
  • Act as designee for the QA manager on local CCRB (Change Control Review Board).
  • Support automation activities, facility programs, and environmental compliance.
  • Collaborate with cross-functional teams to drive process improvements and ensure regulatory compliance.

Requirements & Qualifications:

  • Doctorate Degree OR Master's Degree & 3+ years of directly related experience OR Bachelor's Degree & 5+ years of directly related experience OR Associate's Degree & 10+ years of directly related experience OR High School Diploma/GED & 12+ years of directly related experience

Preferred Qualifications & Skills:

  • Manufacturing process audit & batch record review experience.
  • Familiarity with DAI process, PASx/MES application, MAXIMO, SAP, and LIMS.
  • Strong project management and organizational skills.
  • Ability to initiate and lead cross-functional teams.
  • Strong knowledge of manufacturing, distribution, validation, and process development.
  • Experience interacting with regulatory agencies.
  • Advanced data trending, evaluation, and compliance analysis.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint, and database management).
  • Strong communication, facilitation, and leadership skills.
  • Ability to evaluate and resolve compliance issues independently.


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