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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.
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