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Jobs or company...

Specialist QA

  • Full Time, onsite
  • BioPharma Consulting JAD Group
  • On Site, United States of America
Salary undisclosed

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Job Description

Job Description

The Senior Quality Assurance Specialist will perform key duties in support of Amgen s Quality Assurance program with minimal supervision. This role involves leading quality-related activities such as approving validation protocols, managing investigations, and supporting site audits and facility programs. The Specialist will serve as a key player in ensuring compliance with regulatory standards and will represent QA in cross-functional teams, including New Product Introduction (NPI) and the site Quality Program.

Key Responsibilities:
  • Review and approve product Manufacturing Plans (MPs).
  • Approve process validation protocols and reports for manufacturing processes.
  • Serve as the Quality representative on incident triage teams.
  • Approve Environmental Characterization reports.
  • Oversee the release of sanitary utility systems.
  • Approve planned incidents and manage change controls.
  • Represent QA on the New Product Introduction (NPI) team.
  • Lead investigations related to non-conformance (NC) and Corrective and Preventive Actions (CAPA).
  • Lead internal site audits to ensure compliance with quality standards.
  • Own and manage site quality program procedures.
  • Act as the QA designee on the local Change Control Review Board (CCRB).
  • Review and approve Risk Assessments.
  • Support Automation activities and environmental programs.
  • Review and approve Work Orders, EMS/BMS alarms, and NC investigations.
  • Provide lot disposition and authorize product lots for shipment.
Competencies/Skills:
  • Strong project management and organizational skills with the ability to lead cross-functional teams and ensure completion of assignments.
  • Demonstrated expertise in leading, influencing, and negotiating, with the ability to interact effectively with various stakeholders, including regulatory agencies.
  • Strong knowledge of manufacturing, distribution, validation, QA, QAL, and process development.
  • Proficiency in working with electronic documentation systems such as CDOCS, Maximo, Trackwise, LIMS, MES (electronic batch record), and SAP.
  • Strong ability to evaluate compliance issues and support regulatory inspections.
  • Advanced skills in data trending, evaluation, and the ability to apply GMP standards to risk assessments, IQ/OQ/PQ protocols, and validation processes.
  • Strong communication skills (both written and oral), with facilitation and presentation expertise.
  • Demonstrated ability to work independently and handle multiple projects simultaneously.

Requirements

Required Qualifications:
  • Doctorate degree OR
  • Master s degree with 3 years of directly related experience OR
  • Bachelor s degree with 5 years of directly related experience OR
  • Associate s degree with 10 years of directly related experience OR
  • High school diploma/GED with 12 years of directly related experience.
  • Degree in Sciences or Engineering preferred.
Preferred Qualifications:
  • Expertise in Quality Systems (Deviations, Non-conformities, CAPA, and Change Control).
  • Experience with Validation Master Plans, GMP applications, Risk Assessments, and commissioning activities.
  • Proven experience as a Quality Contact for large-scale projects involving new drug substances/products.
  • Bilingual proficiency in English and Spanish.
  • Experience interacting with regulatory agencies and handling sophisticated compliance issues.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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