Quality Auditor II

FREDERICK, MD
Full Time
Experienced
JOB SUMMARY: The Quality Assurance Auditor II is responsible for ensuring protocols, SOPs, industry and regulatory standards are met or exceeded by performing audits and inspections to confirm service and product compliance, as applicable.
 

ESSENTIAL DUTIES & RESPONSIBILITIES: Employees must be able to perform the essential functions of the job with or without reasonable accommodation.

 
  • Performs assigned inspections
  • Reports study inspection results to StageBio management and the Study Director
  • Prepares a Quality Assurance Statement for each study inspected
  • Maintains a copy of study protocols
  • Inspects facility records and processes
  • Inspects validation packages
  • Assists with client and regulatory inspections
  • Assists with subcontractor inspections and vendor qualifications
  • Maintains strong working knowledge of internal Standard Operating Procedures (SOPs)
  • Trains StageBio Auditors as appropriate
  • Participates in internal training for career development as desired
The physical demands and essential functions described here are representative of those that must be met, with or without reasonable accommodation. 
 

REQUIRED EXPERIENCE/EDUCATION:

  • Pursuit of RQAP-GLP (Registered Quality Assurance Professional in Good Laboratory Practices) certification is encouraged but not required
  • Minimum 2 years’ experience in a GLP quality assurance role and has completed training for at least
the following inspection sub-types: critical phase, data and report
 

REQUIRED SKILLS & ABILITIES:

 
  • Ability to monitor and report on assigned tasks, goals, and objectives
  • Ability and willingness to meet deadlines
  • Proficient with Microsoft Office Applications (Word, Excel, Outlook)
  • Ability to work independently and in a group on a variety of projects
  • Ability to maintain a high degree of accuracy, attention to detail and able to hold staff accountable
  • Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively
  • Capable of understanding FDA regulations
  • Effective communicator both verbally and in writing
  • Ability to use independent judgement concerning matters of significance
 

WORKING CONDITIONS / PHYSICAL REQUIREMENTS:

 
  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift up to 5 lbs. at a time.
  • Days and hours of work are generally Monday through Friday, 8:00 a.m. to 5:00 p.m. with some evenings and weekends as needed

StageBio offers a comprehensive benefits package that includes employer sponsored health insurance, short-term and long-term disability, AD&D, life insurance for employees and dependents, flexible paid time off, 401(k) with match, and paid standard and floating holidays. Salary is commensurate with experience. StageBio is an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, national origin, disability, or status as a protected veteran.

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