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Quality Specialist II

Your role:

The Quality Assurance Unit is responsible for auditing studies at various stages to assure that they are compliant with application regulations. The incumbent performs audits in a scope defined by the manager. He/she understands and interprets the applicable regulations and possesses basic scientific knowledge of the audit scope. The incumbent provides an independent review or audit of data, processes and reports for the assigned audit scope.  Leads others in the interpretation of the regulations, and applicable protocols and SOPs.

 

ESSENTIAL JOB FUNCTIONS

  • Proven background and understanding of GLP compliance and familiarity with all aspects of FDA, EPA, and applicable international regulations.
  • Good understanding of complex and evolving regulatory requirements and intent.
  • Assure the protocol requirements are met by auditing the protocol, raw data, data summary tables, draft and final reports associated with nonclinical studies to evaluate regulatory compliance.
  • Plan, conduct and report study-specific laboratory inspections to assess compliance with GLP regulations/industry standards.
  • Assure QA departmental inspection reports and any other supporting documentation or required records are appropriately processed and eventually archived, as appropriate.
  • Identify regulatory compliance issues and provide regulatory support to departments. 
  • Constructively interact and communicate with employees in various settings.
  • An understanding of laboratory quality assurance principles to ISO 17025 and their application as specified in the Quality Manual
  • Keep QAU and QA Management apprised of compliance issues through frequent updates.

 

EXPANDED JOB FUNCTIONS

  • Co-host and learn to host client visits and regulatory inspections.
  • Serve as a Liaison with operations departments to support consistent practice and advice.
  • Assist in leading facility audits
  • Learn to perform vendor/subcontractor audits
  • May provide training and guidance to QAU personnel.
  • May assist in the planning, development, and delivery of comprehensive GLP Training Programs as needed.
  • Learn to audit another discipline (genetic toxicology, mammalian toxicology, AHS).
  • Participate in and learn to lead departmental business, process, or general regulatory projects.

 

Who you are:

Minimum Qualifications:

  • Bachelor’s Degree in a Science discipline and 2+ years of experience working in quality assurance in a GLP regulated auditing environment, OR 5+ years of experience working in GLP regulated auditing environment in laboratory/facility in lieu of a degree.  

 

Preferred Qualifications:

  • A highly motivated and detail-oriented individual with proven organizational skills, working knowledge of a research laboratory, and proven experience in conducting detailed external and internal audits.
  • Possess good interpersonal and verbal/written communication skills with the ability to interact with all levels of management.
  • Independently determines and develops approach to solutions.
  • Proficiency with Microsoft Office Products (Word, Excel, PowerPoint) spreadsheets and database software applications.
  • Work with minimal supervision and independently determine corrective actions.
  • RQAP-GLP, or other applicable certification or registration desirable

     

Physical Attributes:

  • Pre-Employment testing requirements
  • PFT and Hep B vaccine in addition to routing physical and blood work at Occupational Health Consultants
  • Physical Requirements (PPE, lifting)
  • Ability to use respirators

 

Job Requisition ID:  187982
Location:  Rockville
Career Level:  C - Professional (1-3 years)
Working time model:  full-time


Job Segment: Genetics, Toxicology, QA, Quality Assurance, Science, Quality, Technology

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