QA Sr. Associate, Supplier Quality
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 Sr. Associate will support the Supplier Quality Team helping ensure a successful supplier quality program. This individual will contribute to supplier qualification, supplier monitoring activities, supplier change notifications, and supplier corrective actions. The position would also be exposed to other quality areas and would help with cross functional needs.
Reports to Associate Director, Supplier Quality
Work Location Thousand Oaks, CA
Travel None
Primary Responsibilities:
- Helps maintain list of approved suppliers/service providers.
- Sends self-assessment surveys and additional qualification documents to suppliers to support their addition to the approved supplier list.
- Maintains supplier files and ensures they are up-to-date and readily available in the site’s electronic documentation system.
- Contributes to the development of supplier quality forms and helps route forms through the document control team.
- Logs supplier change notifications and schedules supplier change notification meetings.
- Documents supplier corrective actions and works with supplier on a timely and adequate response.
- Updates supplier monitoring details for suppliers
- Supports quality team with any cross-functional needs.
- Communicates with suppliers to ensure current documentation is correct and to procure additional documentation specific to raw material onboarding.
Qualifications:
- Master of Science (M.Sc.) with 1-2 years of applicable industry experience; or
- Bachelor of Science (B.Sc.) with 2+ years of applicable industry experience; or
- Associate Degree with 4+ years of applicable industry experience; or
- High school diploma with 7+ of applicable industry experience
- Working knowledge of quality management systems and continuous process improvement principles including global cGMP requirements, and other relevant regulations and guidance to assure quality products.
- Working knowledge in the cGMP requirements pertaining to cell therapy manufacturing operations in the United States and globally in support of global clinical and commercial production activities.
- Experience with cGMP, manufacturing, and testing requirements as they relate to biologics, experience with cell therapy processes.
- Demonstrated ability to work in a multi-disciplinary setting
- Scientific/technical skills
- Ability to anticipate and resolve problems effectively
- Strong verbal communication and technical writing skills
- Ability to present clearly using scientific and clinical terminology
- Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings
- Sound organizational skills
- Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions
- Focus on delivery of results
- Detail-oriented
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.
- Nice to have: Experience in aseptic technique/operations, clean room procedures/processes, environmental monitoring programs and media simulation studies.
Salary and Benefits:
- $40 to $50 per hour, depending on experience
- Medical, Dental and Vision
- Life Insurance
- 401k
- Paid Time Off
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.
