Quality Assurance Officer, HGCTF - Dean's Office

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.