Under the supervision of the QA Manager of the Human Gene and Cell Therapy Facility (HGCTF), the HGCTF QA Officer is responsible for the day-to-day Good Manufacturing Practices (GMP) quality assurance compliance activities including document control testing of these products to ensure that the products meet the required quality.

The QA Officer must have knowledge of GMP quality assurance compliance activities including management of OOS, deviations, CAPA and change control documents, releasing reagents per established procedures, establishing quality standards relating to QA/QC to ensure that the organization meets applicable State, Federal and accrediting agency regulatory requirements, actively monitoring changes in the Federal regulations and other accrediting agencies’ standards to ensure continued compliance with current regulations and standards, and maintaining core competencies as a Quality Assurance Inspector. Responsible for writing, reviewing and approval of Master Production (batch) Records, Standard Operating Procedures (SOPs), worksheets, forms, Specifications, Validation Protocols and reports, and Production Record Control systems to ensure compliance. The QA Officer is responsible for evaluating and interpreting regulations and standards to determine applicability and for effectively communicating such applicability. They will also perform routine audits and inspections to ensure compliance and provide written reports of such, ensuring appropriate responses and follow-up. They must ensure issues of critical non-compliance are handled in an appropriate and timely manner.

Annual Salary Range: $82,425.00 - $171,780.00

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.
• Demonstrated ability to develop and monitor quality improvement plans and SOPs.