The QC Microbiology Specialist acts as the technical expert for a microbiology laboratory, writing method validation protocols and reports for new product introductions. Key responsibilities include providing technical support for bioburden, endotoxin, sterility, and mycoplasma testing, designing special studies, troubleshooting assays, and approving lab investigations. Candidates require a Bachelor's degree with four years of directly related experience, or a Master's degree with two years of experience, alongside strong knowledge of GMP regulations.
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)
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