Senior Associate, Quality Assurance for Manufacturing

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 Senior Associate, Quality Assurance for MFG, supports and provides quality oversight to MFG operations and identifies and drives continuous improvements. 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 California (FDBC). This position interacts cross-functionally with Manufacturing, Quality Control, Supply Chain, Validation, MSAT, and with FDB Clients to ensure on time delivery is met.

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 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 Senior Associate, Quality Assurance for MFG, supports and provides quality oversight to MFG operations and identifies and drives continuous improvements. 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 California (FDBC). This position interacts cross-functionally with Manufacturing, Quality Control, Supply Chain, Validation, MSAT, and with FDB Clients to ensure on time delivery is met.

 

Reports to: Senior Manager, QA for Manufacturing

Location: Thousand Oaks, CA (On-site job)

 

Primary Responsibilities:

• Provide quality oversight ensuring CGMP requirements are met for Clinical and Commercial material.
• 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 support for minor deviations, CAPA implementation, change control records, or other quality records, as needed.
• Collaborates with QA colleagues to ensure integration of GMP batch disposition requirements.
• Perform review of Quality documentation such as SOPs, equipment, system, process, master batch records, risk assessments, protocols, and technical reports
• Draft and revise SOPs, work instructions, and other controlled documents.
• Supports internal audits and inspections.
• Performs other duties as assigned.
• Work independently under general supervision and direction.

 

Physical Requirements:

Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels. Work is generally performed in a manufacturing and office environment.

 

Qualifications:

• Experience in manufacturing operations and quality assurance in a cell therapy company (preferred).
• Knowledgeable of aseptic techniques and clean room practices.
• Strong understanding of Quality Management Systems: deviations, CAPA, Change control.
• Attention to detail with strong analytical and problem-solving skills.
• Strong independent judgment and decision-making abilities
• Able to obtain gown certification and gain entry to manufacturing areas.
• Must possess excellent verbal and written communication skills; good interpersonal skills.
• Flexibility in working schedule, i.e., off hours, second shift, weekend.
• Demonstrate ability to work in a team environment to develop, implement and deliver on goals.

 

Education and Professional Experience:

• Master of Science with 0-2 years of relevant experience; OR Bachelor of Science with 2+ years of relevant experience; OR Associates Degree with 4+ years of experience; OR high school diploma with 7+ years of experience.
• Minimum of 2 years+ of related Pharmaceutical or Biotech industry experience in GMP regulated Biologics or Pharmaceutical environment preferr