Senior Specialist, Quality Assurance

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Senior Specialist, Quality Assurance will report directly to the Senior Manager, QA for Manufacturing at FUJIFILM Diosynth Biotechnologies. The job holder will be responsible for managing batch record review activities. They will work cross-functionally to ensure timely documentation and implementation of effective CAPA's.

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.

Senior Specialist Quality Assurance, QA for Manufacturing, is responsible for ensuring quality and compliance of manufacturing operations and to identify and drive continuous improvement. This role is instrumental in ensuring supply to patients by ensuring CGMP requirements are met for Clinical and Commercial material produced at Fujifilm Diosynth Biotechnologies. This position interacts cross-functionally with Manufacturing, Supply Chain, Quality Control, Validation, and with FDB Clients to ensure on time delivery is met.

Reports to                Senior Manager, QA for Manufacturing

Work Location         Thousand Oaks, CA 

Primary Responsibilities:

• Independently perform and manage batch record review activities for production including, but not limited to, review of batch records, media records, material reconciliation, labeling and other documents.
• Provides quality oversight ensuring CGMP requirements are met for Clinical and Commercial material.
• Establishes collaborative relationships with internal and external stakeholders to ensure timely documentation, resolution of quality issues, and implementation of effective CAPAs.
• Review & approve any deviations, change proposals or other quality records, as needed, to support production.
• Perform review and approval of Quality documentation such as SOPs, equipment, system, process, master batch records, change control, risk assessments, protocols and technical reports.
• Author and revise Quality Assurance SOPs, forms, and other controlled documents.
• Identify and support continuous improvement projects in collaboration with different cross functional teams to drive manufacturing reliability and enhance quality and efficiency.
• Performs other duties as assigned.
• Supports GMP inspections and audits from both regulatory authorities and clients.
• Collaborates with QA colleagues to ensure integration of GMP batch disposition requirements. 

Qualifications:

• Master of Science with 4+ years of applicable industry experience OR Bachelor of Science with 6+ years of applicable industry experience OR Associate Degree with 8+ years of applicable industry experience OR High school diploma with 11+ years of applicable industry experience.
• Experience in manufacturing operations and quality assurance preferred.
• Knowledge in Aseptic Processing and ability to gown into controlled cleanroom environments, as needed.
• Ability to self-manage and work effectively with internal & external stakeholders and parties, with minimal oversight.
• Attention to detail with strong analytical and problem-solving skills.
• Must possess excellent verbal and written communication skills; good interpersonal skills.
• Flexibility in working schedule (i.e., off hours, second shift, weekend).
• 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.