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Specialist, GLP Compliance

Assist in the evaluation of compliance of nonclinical and bioanalytical studies conducted by BioMarin to FDA Good Laboratory Practices (GLP) regulations and any other applicable GLP international regulations and guidelines, and to corporate policies and standard operating procedures (SOPs). Perform domestic GLP audits to assess the company's compliance to FDA government regulations, scientific protocols and internal SOPs as they relate to GLP Quality Assurance and regulatory GLP compliance.  In addition, assist in performing internal systems audits and reviews. Communicate findings to the appropriate scientists and management. Assist with GLP regulatory compliance training and with special GLP Compliance systems and corporate projects. 

 

  • Works on problems of limited scope. Follows standard practice and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally.
  • Normally receives detailed instructions on all work assignments.
  • As appropriately trained, assist in the review of study protocols, raw data, data summary tables, technical reports, final reports and submission documents associated with nonclinical and bioanalytical studies (method validations and study sample analysis) conducted by BioMarin to evaluate regulatory compliance.
  • As appropriately trained, conduct and report study-specific, process-based, CRO and internal BioMarin facility audits and inspections to assess compliance with GLP regulations and industry standards.
  • As appropriately trained with supporting FDA and other regulatory inspections and requests during inspections. Procure Inspection Readiness documents/tools, organize inspection role playing and preparation activities as assigned. Assist in building eTools that support Inspection Readiness of GLP operations.
  • Assure GLP Compliance departmental inspection reports and any other supporting documentation or required records are appropriately processed in the database and archives.
  • Identify regulatory compliance issues and provide basic regulatory support to the BioMarin regulated departments. 
  • Assist in the continued development and guidance of administration programs to promote and monitor the quality and performance of operations as they relate to both nonclinical and bioanalytical projects.
  • Be capable of gaining proficiency on regulatory compliance issues and to assist with required training to laboratory personnel.
  • Effectively interact and communicate with BioMarin employees in intra departmental settings.
  • Prepare Metrics reports, keep Corporate Compliance & Ethics Management appraised of compliance and personnel issues through frequent communication.
  • Assist in writing, revising and preparing SOPs

 

  • Experience in Biology, Chemistry, or applicable Life Science with a minimum of 0-2 years related experience in GLP and/or GxP programs.  Requires a BS degree in scientific discipline. Additional experience in GCP and/or GMP QA, a plus.
  • General understanding of GLP compliance and familiar with the basic aspects of FDA and other applicable international regulations. General understanding of complex and evolving regulatory requirements and intent.
  • Basic experience in auditing or relevant laboratory/facility setting experience.
  • Possess good interpersonal, organizational and verbal/written communication skills.
  • Basic computer skills (eg, Microsoft Office) and highly-motivated, detail-oriented, and develops the versatility to work independently or in a team-oriented environment.
  • The ability to travel (~20%).
  • Works under general direction with minimal supervision.

 

Minimum/Required: Bachelor’s (BA/BS) in a Life Science or closely related field of stud

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