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Quality Assurance Analyst

Summary:

Ensure that all company’s business conform to applicable Good Laboratory Practice (GLP) regulations (including FDA, OECD, EPA and MHLW) and ensure employees and company are following applicable Standard Operating Procedures. 

Duties and Responsibilities

  • Audit protocols, data, reports and conduct experimental phase audits to ensure compliance with applicable regulations and Standard Operating Procedures (SOPs). 
  • Perform Facility Inspections
  • Perform process audits to ensure Standard Operating Procedures (SOPs) are
  • Effectively communicate audit findings to Study Director and Management as necessary
  • Prepare QA Statements as appropriate
  • Write/ review Standard Operating Procedures (SOPs)
  • Assist in maintaining training files
  • Attend meetings as requested
  • Travel as needed to conduct the above responsibilities
  • Assist during/host client audits as needed
  • Audit Vendor/Subcontractor sites as required
  • Maintain proficiency in designated regulations
  • Maintain proficiency in company Standard Operating Procedures
  • Assist during agency inspections
  • Flexibility to learn potentially new

Qualifications

Education:  Bachelor’s Degree (B.S. or B.A) in biology, chemistry, or related discipline from a four-year college or university. Experience of 2 plus years of auditing is preferred and/or RQAP-GLP certification.

 

Language:  Ability to read, analyze and interpret common scientific and technical journals, etc.  Must have good communication skills and be able to effectively communicate via verbal communication and written communication.

 

Mathematical Skills:  Ability to apply advanced concepts and formulas to certain procedures.

 

Reasoning Ability:  Ability to apply principles of scientific or logical thinking to a wide range of situations.  Ability to use independent thinking to make judgement calls as necessary in situations open to interpretation.  Must be thorough, detail-oriented and precise.

 

Other Skills: Strong inter-personal skills are a must for the candidate as well as conflict-resolution.  Ability to use personal computers and appropriate equipment (printers, scanners, etc).  Proficient in typing and good knowledge of software programs such as Microsoft Word, Excel, PowerPoint, etc.  Ability to learn new software in-house applications as needed.

 

Work Environment

  • While performing the duties of this job listed above, the employee is required to sit and to stand for extended periods of time. 
  • While performing the duties of this job, the employee may incidentally be exposed to fumes, airborne particles, toxic or caustic chemicals, biohazard material and radiation. 
  • Accommodations may be made per each situation.

 

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