Senior Specialist, 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 FDB and help manufacture the next vaccine, cure, gene, or 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.

External US

FUJIFILM Diosynth Biotechnologies California, Inc.

Sr. Specialist, Quality Assurance

Newbury Park, CA

 

Job Duties: Ensure quality and compliance of manufacturing operations. Identify and drive continuous improvement. Ensure supply to patients by ensuring CGMP requirements are met for Clinical and Commercial material produced at FDBC. Perform batch record review activities for production including, but not limited to, review of batch records, media records, material reconciliation, labeling and other documents. Provide quality oversight ensuring CGMP requirements are met for Clinical and Commercial material. Perform timely documentation, resolution of quality issues, and implementation of effective CAPAs. Review any deviations, change proposals or other quality records, as needed, to support production. Perform review 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. Support GMP inspections and audits from both regulatory authorities and clients. Ensure integration of GMP batch disposition requirements. Employ internal audit compliance methodologies including CAPA, Six Sigma, Gap Analysis, ISO 9001, ISO 13485, FMEA, DFMEA & PFMEA, DOE, IQ, OQ, PQ, Kaizen, EV. Utilize GXP enterprise systems and quality systems including SOPs and Change Control. Apply aseptic processing techniques. Support manufacturing operations.

 

 

Requirements: Bachelor’s Degree in Technology, Mechanical Engineering, or related field and five (5) years of experience in position offered or related position OR Masters Degree in Technology, Mechanical Engineering, or related field and two (2) years of experience in position offered or related position. Must have two (2) years of experience in a biopharmaceutical industry employing internal audit compliance methodologies including CAPA, Six Sigma, Gap Analysis, ISO 9001, ISO 13485, FMEA, DFMEA & PFMEA, DOE, IQ, OQ, PQ, Kaizen, EV; utilizing GXP enterprise systems and quality systems including SOPs and Change Control; applying aseptic processing techniques; and supporting manufacturing operations.

 

 

* Employer will accept any suitable combination of experience, education, or training.

 

Salary: $120,000 - $130,000