Job Information
Fujifilm Specialist Quality Assurance, Compliance in Thousand Oaks, California
Overview
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 FDBC 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 Specialist QA, Compliance supports the Cellular Therapy GMP quality program. This individual is responsible for the management of the Internal Quality Audit Program and facilitates Client Audits and supports Regulatory Agency Inspections. Acts as business process owner (BPO) for the Audits and Inspections process and Risk Management Process
External US
Specialist QA, Compliance
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 FDBC 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 Specialist QA, Compliance supports the Cellular Therapy GMP quality program. This individual is responsible for the management of the Internal Quality Audit Program and facilitates Client Audits and supports Regulatory Agency Inspections. Acts as business process owner (BPO) for the Audits and Inspections process and Risk Management Process.
Specific responsibility for Audits and Inspections: establishing, implementing, monitoring and reviewing the self inspection process; developing, approving, and maintaining the self inspection schedule; ensuring lead auditors and auditors have appropriate qualifications, and facilitating and coordinating activities for external audits and inspections.
Specific responsibility for Risk Management: maintaining the Risk Management SOP and related training, owning and updating the Risk Register, Facilitating Risk Assessments and maintaining a list of qualified Risk Facilitators.
Reports to Associate Director of Compliance
Work Location Thousand Oaks, CA
Travel Not required
Primary Responsibilities:
Business Process Owner for Audits and Inspections
Sets the requirements for the Self Inspection Program
Defines the Self Inspection Schedule
Manages training for Internal Auditors
Supports training for external inspection support staff
Develop a pool of internal auditors
Supports the Inspection Readiness Program
Facilitates and coordinates Client audits; supports regulatory agency inspections
Maintain policies, procedures for the Self Inspection and Risk Management Programs
Monitors and reports on compliance to commitment dates
Supports GMP inspections and Client audits and supports drafting of follow-up responses for all aspects of the business
Risk Assessment Facilitator
Develops a pool of Risk Facilitators
Updates and maintains the Risk Register
Reports on Major and Critical risks and risk mitigations
Supports site operations on risk tool selection
Supports other GXP functions as required
Qualifications
Master of Science (M.Sc.) with 2+ years of applicable industry experience; or
Bachelor of Science (B.Sc.) with 4+ years of applicable industry experience; or
Associate Degree with 6+ years of applicable industry experience; or
High school diploma with 9+ of applicable industry experience
Experience with commercial facility pre-approval inspection (PAI) and PAI readiness planning a plus
Experience with Risk Management a plus
Experience with Regulatory Intelligence a plus
Solid understanding of quality management systems and continuous process improvement principles including global cGMP requirements
Working knowledge in the cGMP requirements pertaining to sterile drug product manufacturing operations in the United States and globally in support of global clinical and commercial production activities
Experience in aseptic technique/operations, clean room procedures/processes, environmental monitoring programs and media simulation studies
Experience with cGMP, manufacturing, and testing requirements as they relate to biologics, experience with cell therapy processes a plus
Demonstrated ability to work in a multi-disciplinary setting
Strong 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 settings
Sound organizational skills
Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions
Project management skills and focus on delivery of results
Role model for company core values of trust, delighting our customers, Gemba, and Genki
Salary and Benefits:
$104,000 to $130,000 per year, 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.
Job Locations US-CA-Thousand Oaks
Posted Date 2 months ago (8/16/2024 4:18 PM)
Requisition ID 2024-27751
Category Quality Assurance
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies
Fujifilm
- Fujifilm Jobs