Description
UCLA HEALTH
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Description
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
Qualifications
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.