The QC Production Associate will perform QC testing of raw materials and reagents for release, stability, in-process testing and assay development. Participate in new product introduction teams to perform assay development, optimization, and transfer oligo based products into Fluidigm?s Reagent Manufacturing and/or Assay Design Group.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Essential duties include but are not limited to:
%
Duties and Responsibilities
50%
QC incoming raw materials, in-process testing, and final QC of oligo based products. Analyze data and complete testing report.
30%
Work with R&D and Tech Support to transfer new products into reagent manufacturing and/or Assay Design Group.
10%
Assist in the Development of QC procedures, create and maintain QC documentation for new and existing products, processes, and equipment.
5%
Create and maintain a reagent stability program.
5%
Assist manufacturing with filling/packaging events as requested.
QUALIFICATIONS:
Education and Experience
Bachelor's degree in Biology, Chemistry, or related field or comparable industry experience and 8+ years Biotech, Medical Device, or Pharmaceutical industry experience.
Master?s degree in Biology, Chemistry or related field and 4+ years Biotech, medical device or Pharmaceutical industry experience.
Knowledge/Skills/Abilities:
Significant experience in PCR and other Molecular Biology techniques.
Experience with Quality Control methods development and implementation.
Experience with new product transfer and scale-up
Special consideration given to those with experience in an ISO/GMP/GLP facility.