Manager, Laboratory Services (Bone Marrow Transplant) - BMT Lab Quality - Part Time 8 Hour Days (Exempt) (Non-Union)

The Manager of Laboratory Services (Bone Marrow Transplant) has the responsibility of quality management program for the BMT laboratory.

The positions is responsible for the management, development, maintenance, and ongoing activities of BMT laboratory quality program of the Norris Comprehensive Cancer Center.

This position will also responsible for quality audits, documenting planned and unplanned deviation. Duty will include, but not limited to, CAPA risk assessment of new, updated procedures and occurrences.

Quality Manager will establishes new polices, if necessary, to monitor compliance with FACT standard, FDA, and California Health Department.

As needed, the position will develops, validates, and implements new procedures as it relates to the quality program.

Essential Duties :

Quality Control Program Management : Development and updates of BMT Laboratory Quality Plan. Performing equipment and processes validations.

Responsible for BMT Laboratory Quality Audits. Evaluating, documenting, and reporting unplanned deviations. Identifying & preparing planned deviation reports and communicating it to Medical Director.

Performing root cause analysis and CAPA risk assessment of the occurrences like deviations, accidents, errors and complaints event.

Qualification / verification / documentation of Service suppliers and critical reagents manufacturers. Performing and analyzing CTPs stability study.

Preparation for inspections by regulatory agencies FDA, FACT. External audits coordinator by regulatory institutions. Reviewing storage of CTPs in LN tanks.

Assisting in audits by pharmaceutical companies. Record keeping, archiving. Car T -FDA approved cell therapy products. Participating in Site Initiation Visit (SIV).

Developing updating SOPs (if needed). Establish cooperation with other Norris / Keck Hospital's department (oncology surgery).

Take part in training by pharmaceutical company. Share and assign responsibilities between BMT lab personnel. Validation of new procedures, equipment's, processes (if applicable).

Setting up cooperation with other departments in Norris / Keck hospitals. Training other lab personnel. Record keeping and communication with companies' websites (chain of custody for immune effector cells).

• Implements and ensures compliance with the operating policies and procedures of the department by regular monitoring of all activities in the laboratory.
• Implements and ensures compliance with hospital / university policies and procedures as it relates to Safety, Infection Control, Human Resources, HIPAA, Employee Health, Information Systems, etc.
• Reinforces the use of personal protective equipment by staff and maintains a safe work environment by requiring safe work practices.
• As directed by the Medical Director as part of BMT Quality Plan (and collaboration with the per diem senior CLS who audits her processing work) collects, reviews and prepares QC, QA, and internal audit reports for presentation to the quarterly QM meetings, Hospital leadership and MOTC with recommendations for improvement.

Conducts regular review of all quality control, maintenance records, processing records, etc to ensure accuracy and completeness of documentation and compliance with laboratory standards and SOP's.

Reports deviations of SOP's to the Medical Director immediately and performs corrective action.

• Ensures equipment are maintained and operating at all times by scheduling maintenance calls, and troubleshooting problems.
• Coordinates and integrates department services on intradepartmental, interdepartmental and hospital-wide levels.
• Other duties and special projects as assigned.

Required Qualifications :

• Req Bachelor's Degree
• If no Bachelor's Degree, must have Associate's Degree with additional 4 years of experience in clinical laboratory.
• Req 3 years Experience with clinical laboratory with familiarity with Bone Marrow Transplant
• Req Knowledge of medical procedures like apheresis, in accordance with administrative and clinical policies, regulations and procedures.
• Req Knowledge of GMP (good manufacturing practice in accordance with FDA, AABB, and State requirements.
• Req Excellent written and verbal communication skills.
• Req Able to function independently and as a member of a team.
• Req Competence in creating project documentation.
• Req Computer skills including Microsoft Office applications.
• Req Ability to manage and coordinate medium size groups.
• Req Critical thinking skills, decisive judgment and the ability to work with minimal supervision.
• Req Must be able to work in a stressful environment and take appropriate action.

Preferred Qualifications :

Pref Clinical Laboratory Scientist - CLS

Required Licenses / Certifications :

Req Fire Life Safety Training (LA City) If no card upon hire, one must be obtained within 30 days of hire and maintained by renewal before expiration date.

Required within LA City only)

The annual base salary range for this position is $66,560.00 - $90,948.00. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education / training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.