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Employer Job Description
From BioPharma Consulting JAD Group's posting. “We” and “our” refer to the employer.
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)
About this listing
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