Senior Associate Supply Chain, Quality Assurance

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 Supply Chain, Quality Assurance supports the supply chain operation at Fujifilm Diosynth Biotechnologies facility at California (FDBC), focus on labeling and packaging operation, inspection of the GMP material and stock transfer. This includes but not limited to performing production order document review, label printing and issuance, quality oversight over packaging operation, batch record review, and inspection of material and stock transfer process. This position interacts cross-functionally with all areas of Quality, Supply Chain, and New Product Introduction team.

External US

 

Sr. Associate Supply Chain QA

 

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 Supply Chain, Quality Assurance supports the supply chain operation at Fujifilm Diosynth Biotechnologies facility at California (FDBC), focus on labeling and packaging operation, inspection of the GMP material and stock transfer. This includes but not limited to performing production order document review, label printing and issuance, quality oversight over packaging operation, batch record review, and inspection of material and stock transfer process. This position interacts cross-functionally with all areas of Quality, Supply Chain, and New Product Introduction team.

 

Reports to: Manager, Quality Operations

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

 

Primary Responsibilities:

• Perform quality review of production order document.
• Perform label printing and issuance.
• Perform quality oversight over packaging operation.
• Performs batch record review of final packaged products.
• Perform inspections of the incoming GMP material and stock transfer Participate in routine quality Gemba walk of the GMP warehouse and operations.
• Serves as quality contact and support minor deviations and CAPA implementation.
• Drafts and approves related controlled documents such as SOPs, Work Instructions, and Forms
• Supports internal audits and inspections.

 

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, with some warehouse environment work.

 

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 preferred.
• Experience with Contract Manufacturing Organizations is a plus.

 

Skills and Abilities:

• Ability to gown and gain entry to manufacturing areas.
• 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.

 

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 ph