This job has expired

You will need to login before you can apply for a job.

Senior Quality Control Associate

Employer
FUJIFILM Diosynth Biotechnologies
Location
Thousand Oaks, CA
Start date
Nov 24, 2022

View more

Discipline
Quality, Quality Control
Required Education
Associate Degree
Position Type
Full time
Hotbed
Biotech Beach
You need to sign in or create an account to save a job.

Job Details

This role supports the Quality Control and manufacturing operations by executing QC analytical assays for in-process, product release and stability with emphasis in cell-based bioassays (e.g., viable cell count, Immunophenotyping, cytotoxicity assays). The candidate must have GMP laboratory and bioassay, cell biology or immunology experience.  The selected individual will be expected to support cell culture, routine GMP testing, QC projects for clinical and commercial products in compliance with GMP regulations.

Reports to Sr Manager, Quality Control

Location     Thousand Oaks, CA

  

Primary Responsibilities

  • Performs routine testing for in-process, intermediates, final product, and stability of clinical and/or commercial lots.
  • Act as subject matter expert for analytical methods, troubleshooting, investigations and/or technical reports
  • May participate in the analytical method transfer and/or validation, as well as critical reagents qualifications 
  • Draft and review laboratory SOPs, test methods and technical documents.
  • Train QC Associates
  • Participate of internal and external inspections and audits as subject matter expert
  • Support nonconformance investigations, root cause analysis and implement solutions
  • Support laboratory equipment validations, as needed
  • Ensure compliance with applicable company requirements and global regulations

 

Qualifications

  • Bachelor of Science (B.Sc.) with 3+ years of experience or an equivalent combination of education and experience; or Master of Science (M.Sc.) with 0-3 years of experience
  • Experience in cell-based bioassay and cell culture is a must.
  • Quality control experience in the pharmaceutical industry supporting cGMP areas
  • Experience in cGMP cell therapy manufacturing and/or testing facility is a plus.
  • Role model for company core values of trust, delighting our customers, Gemba, and Genki.

 

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.

 

 

Company

FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.

With over 30 years of experience in process development and cGMP manufacturing, a dedicated staff of over 2,000 and a reputation for excellent customer service, flexibility and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry.

Our Process Development experience includes the development of processes for molecules expressed via fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.

Our network expands within five development and manufacturing facilities located in Teesside, United Kingdom; Research Triangle Park, North Carolina, USA; College Station, Texas, Thousand Oaks CA USA and Hillerød, Denmark.

FacebookTwitter

Find Us
Website
Phone
919-337-4400
Location
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
Watertown, MA
US
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert