Текст заказа
Be the technical specialist for the microbiology lab at a leading biotechnology company in Juncos, Puerto Rico, supporting method validations for new product introductions.
What you'll do
* Write microbiology method validation (MMV) protocols and reports for new product introductions.
* Provide technical support to the microbiology lab: bioburden, endotoxin, low endotoxin recovery, sterility and mycoplasma testing.
* Design special studies and troubleshoot assays.
* Support deviation owners in evaluating events and root causes; approve lab investigations.
* Develop, revise and audit controlled documents and support lab compliance with GMP/GLP.
Requirements
* Bachelor's + 4 years (or Master's + 2, or Doctorate) of directly related experience; microbiology background preferred.
* Microbiology method validation and technical writing.
* Bioburden, endotoxin (including low endotoxin recovery), sterility, MMV and mycoplasma testing.
* Strong knowledge of GMPs/CFRs and U.S. regulations for testing biological products.
* Data analysis, trending and complex problem solving.
* Bilingual English/Spanish preferred.
Benefits
* Contract: 2.5 months, with possible extension
* Shift: Administrative, Monday–Friday 8:00 am–5:00 pm (overtime upon business needs)