Regulatory Compliance Manager

hace 7 días


Juncos, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

Quality Assurance Specialist Job Description

We are seeking a Quality Assurance Specialist to join our team at Biopharma Consulting Jad Group. The successful 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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