Responsibilities
Under the supervision of the Lead QA officer and Director of the Human Gene and Cell Therapy Facility (HGCTF), you will be responsible for the day-to-day GMP quality assurance compliance activities including management of OOS, deviations, CAPA and change control documents and releasing reagents per established procedures.
You will also be responsible for 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.
Among other duties, you will also be 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.
Qualifications
Bachelor of Science Degree or Master’s degree in Biology, Chemistry, or related field strongly preferred
A minimum of one year of GMP quality assurance experience
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.
On occasion, ability to work flexible hours.
Ability to attend off-site staff meetings, conferences and investigator meetings.
Exceptional database and computing skills.
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 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.
UCLA is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.