Quality Assurance Lead for Manufacturing Process

hace 7 días


Juncos, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

About Us: Biopharma Consulting Jad Group is a leading consulting firm dedicated to providing expert guidance on quality assurance and regulatory compliance. Our team of experts helps pharmaceutical and biotechnology companies navigate complex regulatory requirements and ensure the highest standards of quality in their manufacturing processes.

Salary: $120,000 - $180,000 per annum, depending on experience

Job Description:

We are seeking an experienced Quality Assurance Lead to join our team. The ideal candidate will have expertise in quality systems, including deviations, CAPA, and change control. They will be responsible for reviewing and approving manufacturing processes, risk assessments, and compliance activities. This position requires strong leadership and project management skills, as well as excellent analytical and communication skills.

Main Responsibilities:

  • Review and approve manufacturing processes (MPs) and validation protocols/reports
  • Represent Quality Assurance on incident triage and New Product Introduction (NPI) teams
  • Lead site audits, investigations, and environmental characterization assessments
  • Oversee the release of sanitary utility systems and approve planned incidents and risk assessments
  • Serve as a QA designee on the local Change Control Review Board (CCRB)
  • Approve non-conformance (NC) investigations, Corrective and Preventive Actions (CAPA) records, and change controls
  • Authorize lot disposition for shipment and oversee lot approvals
  • Support automation, facilities, and environmental programs as required
  • Review and approve work orders, EMS/BMS alarms, and quality program procedures

Requirements:

  • Doctorate in Science/Engineering, OR Master's degree in Science/Engineering with 3+ years of related experience, OR Bachelor's degree in Science/Engineering with 5+ years of related experience, OR Associate's degree with 10+ years of related experience, OR High school diploma / GED with 12+ years of related experience
  • Expertise in quality systems such as Deviations, CAPA, and Change Control
  • Hands-on experience with electronic documentation systems, including CDOCS, Maximo, Trackwise, LIMS, MES, and SAP
  • Demonstrated experience in GxP application validation, validation master planning, IQ, OQ, PQ protocols, risk assessment, and summary reports

Preferred Qualifications:

  • Strong communication and presentation skills in both English and Spanish
  • Advanced skills in project management, data trending, and independent problem-solving
  • Enhanced ability to lead cross-functional teams, influence others, and negotiate effectively
  • Experience collaborating with regulatory agencies and addressing compliance issues


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