Quality Assurance Specialist/Senior Specialist

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Quality Assurance Specialist/Senior Specialist will report directly to the Director, Qualty Operations at the FUJIFILM Diosynth Biotechnologies Caiifornia (FDBC) location.  The job holder will be responsbile for understanding regulatory requirements related to QC system and Data.  They will collaborate and lead discussions with other managers to ensure deliverables meet the needs across the organization.

External US

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

The QA for Quality Control position, under the Plant QA organization, supports and provides quality oversight to QC and will be responsible for deviation, change control, CAPA, OOS, OOT, and Invalid Results investigations related to QC events. This role will also serve to review qualification/validation protocols and reports as well as Technical Transfer protocols.  

The successful candidate demonstrates GMP QA leadership, is proficient in communication (written and verbal), multitasks across multiple functional areas, is timeline focused and flexible in their work scheduling to meet the demands of a multi-product cellular therapy company.

Reports to     Director, Quality Operations

Location        Thousand Oaks, CA

Travel            Some travel is required (20%)

Primary Responsibilities:

• Understand regulatory requirements related to QC systems and data. Own the process for quality oversight of Good Laboratory Practices to ensure compliance to regulations.
• Collaborate and lead discussions with other managers to ensure deliverables meet the needs across the organization.
• Support Out of Specification/Trend investigations.
• Review and approve QC validation, technical transfer protocols and reports. Support assay and equipment implementation and modification.
• Provide Quality system record support to achieve on-time closure. Participate in cross-functional team meetings to resolve deviation and CAPA issues.
• Investigate deviations using knowledge of analytical process, technical reports, validation, and equipment.                
• Review, assess, and approve Change Controls plans, and/or records.
• Support lot disposition activities including closure of quality records and approval of Certificates of Analysis.
• Responsible for achieving project milestones within timelines and budget.
• Ensure policies and procedures are adequate and being followed.
• Support regulatory filings and audit readiness initiatives.
• Perform real time documentation review concurrent with operations.
• Act as the Quality representative on the floor during operations, troubleshooting, and system related maintenance.
• Participate in cross-functional team meetings where QA oversight/input is required, facilitates issue resolution through problem-solving and collaboration with colleagues.       
• Draft and revise SOPs, work instructions, and other controlled documents.
• Work independently under general supervision and direction.
• Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion. Perform and support routine quality area walkthroughs and audits.
• Experience with analytical method validation, data integrity and compliance

Qualifications

• Bachelor's Degree in Engineering or Life Sciences with 5+ years of experience in a GMP regulated Biologics or Pharmaceutical environment
• Experience with analytical method validation, data integrity and compliance
• Experience in clinical and/or commercial phase GMP quality operations
• Advanced knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues (21 CFR 210/211, 1271, 2001/83/EC, 2006/17/EC and 2006/86/EC)
• Experience with USP and EP compendial testing
• Experience leading, approving or overseeing laboratory investigations of Out of Specification and Out of Trend analytical results.
• Experience with analytical method qualification, validation, and tech transfer
• Strong understanding of Quality Management Systems: deviations, CAPA, Change control
• Strong independent judgment and decision-making abilities
• An understanding of T-cell biology and the immunological principles of HLA restriction, and alloreactivity (preferred)
• An understanding of, and experience with, polychromatographic flow cytometry as applied to immunophenotyping (preferred)
• Experience with QA/QC in a cell therapy company (preferred)
• Strong understanding of root cause analysis methodology.
• Time-management skills: able to effectively plan and organize work tasks; complete tasks in a timely manner.
• Ability to work both independently with minimal supervision and to work in a team environment to develop, implement and deliver on goals.
• Strong problem solving and critical thinking skills.
• Knowledgeable of aseptic techniques and clean room practices.
• Able to obtain gown certification and gain entry to manufacturing areas.
• Able to work in controlled environments requiring special gowning for biosafety and radiation laboratories.
• High bar personal ethics with a "patients first" value system.
• Flexibility in working schedule, i.e., off hours, second shift, and weekends.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Join us!  FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.