Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Quality Assurance Specialist will report directly to the Manager, Quality Operations at the FUJIFILM Diosynth Biotechnologies California (FDBC) location. The job holder will be responsible for evaluating compliance issues, providing recommendations, and assuring progress of quality records to completion . They will perform and support routine quality audits in Manufacturing.

Quality Assurance Specialist

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 Specialist position provides quality oversight for the production activities at the FUJIFILM Diosynth Biotechnologies California facility. The role will be responsible for ownership, review and approval of quality records including SOPs, MPs & Batch Records, nonconformances, CAPAs, change controls, and work orders. The role will also support product disposition and batch record review activities.

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 clinical phase cellular therapy company that is transitioning to the commercial phase.

Reports to     Manager, Quality Operations

Location        Thousand Oaks, CA

Primary Responsibilities:

• Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
• Works independently under general supervision and direction.
• Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion. Performs real time documentation (batch record, e-batch record, logbook, etc.) review concurrent with manufacturing operations on the manufacturing floor.
• Performs and supports routine quality audits in Manufacturing.
• Reviews and assesses quality system information (i.e. alarm reports, work orders).
• Supports quality systems related to QA for in-process sampling and controls, and all aspects of shop floor QA.
• Acts as the Quality representative on the floor during manufacturing operations and troubleshooting.
• Investigates non-conformances within warehousing and production areas using knowledge of manufacturing process, utilities, and equipment.
• Participates in cross-functional team meetings to resolve non-conformance and CAPA issues.
• Performs activities supporting change controls.
• Cross trains within the area of Batch Review and Release.
• Drafts and revises SOPs, Work Instructions, and other controlled document types.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 5+ years of experience in a cGMP regulated Biologics or Pharmaceutical environment, supporting commercial phase cGMP Quality operations
• Experience in a commercial phase pharmaceutical environment
• Experience with Contract Manufacturing Organizations
• Direct experience participating and supporting regulatory inspections and submissions
• Advanced knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues
• Root Cause Analysis Training
• Experience in 21 CFR 210/211, 1271, 2001/83/EC, 2006/17/EC and 2006/86/EC
• Flexibility in working schedule, i.e., off hours, second shift, weekend
• Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills
• Ability to effectively plan, organize work activities and prioritize task completion to meet deadlines
• Strong problem solving and analytical skills with demonstrated ability to be detail oriented, while managing multiple projects simultaneously
• General understanding of biopharmaceutical development, clinical research, biologics manufacturing, cell therapy manufacturing, project management, and virtual CMO business model.
• Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast- paced and demanding environment.
• Demonstrate ability to work in a team environment to develop, implement and deliver on goals
• Demonstrate ability to work successfully and with appropriate sense of urgency in a nimble fast paced matrixed environment
• Must be a strong team player and ability to collaborate cross functionally
• Must be able to work in controlled environments requiring special gowning for biosafety and radiation laboratories
• High bar personal ethics with a "patients first" value system.
• 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.