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

Date Posted: 6/14/2018

Job Snapshot

  • Employee Type:
  • Location:
    Fremont, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

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