Quality Assurance Officer - HGCTF

Under the supervision of the Director of the Human Gene and
Cell Therapy Facility (HGCTF), the Quality Assurance Officer for the HGCTF is
responsible for the day-to-day Good Manufacturing Practices (GMP) quality
assurance compliance activities including document control.

Annual Salary Range: $78500.00 - 163600.00

All Required:

• Bachelor's or Master's degree
  in Biology, Chemistry, or related field with at least one year of GMP Quality
  Assurance experience; OR a PhD or PharmD with demonstrated knowledge of GMP
  Quality Assurance principles.
• Previous experience directly
  involved with federal regulations regarding GLP and GMP.
• Strong interpersonal
  communication skills to effectively and diplomatically interact with physicians,
  staff, administration & sponsors
• Demonstrated skill in
  gathering pertinent data, preparing narrative reports, statistical reports,
  charts, graphs, and tables.
• Demonstrated ability to carry
  out analytical tasks, to identify and define issues and alternatives, to
  resolve problems, and to draw logical conclusions.
• Demonstrated skill in
  reviewing data and material compiled by others for completeness and accuracy to
  ensure that incorrect/incomplete data is corrected.
• Ability to deal with and
  maintain confidential and sensitive information with discretion. Ability to
  determine what information is confidential and to protect the confidentiality
  of that information.
• On occasion, ability to work
  flexible hours. Ability to attend off-site staff meetings, conferences and
  investigator meetings.
• Excellent English-writing
  skills to compose, proofread correspondence and written reports for
  conciseness, clarity, appropriate grammar, correct spelling, and proper
  punctuation.
• Ability to write concise and
  accurate administrative reports, policies, procedures, and correspondence.
• Working knowledge of some
  medical and scientific terminology for protocol abstracting and conversation
  with research personnel.
• Demonstrated skills with
  personal computers, spreadsheets, databases and word processing applications
  for the maintenance of administrative records, analysis of data, and the
  preparation of reports.Demonstrated skill in utilizing programs such as Word,
  Excel, and other database software. Ability to learn other
  systems/software as required.
• Demonstrated knowledge of FDA
  Good Laboratory Practice, Good Tissue Practice and Good Manufacturing Practice
  guidelines.