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
QC incoming raw materials, in-process testing, and final QC of oligo based products. Analyze data and complete testing report.
Work with R&D and Tech Support to transfer new products into reagent manufacturing and/or Assay Design Group.
Assist in the Development of QC procedures, create and maintain QC documentation for new and existing products, processes, and equipment.
Create and maintain a reagent stability program.
Assist manufacturing with filling/packaging events as requested.
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.
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.