Scientist, Bulk Formulations in Fremont, CA at Apex Life Sciences

Date Posted: 6/14/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Fremont, CA
  • Job Type:
    Science
  • Experience:
    Not Specified
  • Date Posted:
    6/14/2018
  • Job ID:
    858402

Job Description


Position Summary: 


•         Manufactures products for the Bulk Formulations team and completes associated cGMP documentation.


•         Works with chemicals and biologicals to manufacture reagents, calibrators, and controls for IVD use.  


•         Participates in process improvement projects.

Key Responsibilities:    


•         Manufacture products and complete batch records following cGMPS including reagents, calibrators, buffers, controls, etc. 


•         Perform in-process testing using clinical analyzers.


•         Review and analyze data. 


•         Review other manufacturing operators/scientist's batch records.


•         Maintain and analyzes lot histories for trends and discrepancies. 


•         Weigh, transfer, and mix required chemicals


•         Perform product filtrations


•         Participate in process improvement projects to improve efficiencies and support business needs. 


•         May modify SOPs, work instructions and reports with guidance. 


•         Initiate and support investigations for NCARS, CAPAs, and Variances


•         Maintain and troubleshoot equipment as appropriate. 


•         Keep department supervisor and/or manager updated on all issues 


•         Perform other job duties as required. 

Minimum Requirements/Qualifications


•         BS/BA in scientific discipline (Chemistry or Biochemistry preferred) with 0-2 years related experience and/or training preferred.


•         Equivalent combination of education and years of related experience may be substituted.


•         IVD manufacturing experience is a plus


•         Laboratory skills and knowledge of safety precautions  is a plus


•         Experience in working with potentially hazardous chemicals and human source materials is a plus


•         Familiarity with Quality System Regulations and ISO 13485 regulations is a plus


•         Must be able to lift 25 lbs routinely