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Open nowPosted 6 hours agoWe saw it 38 min after it went up

QC Microbiology Specialist - Method Validation and NPI

BioPharma Consulting JAD Group

Where
Juncos, Puerto Rico
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Your applicationOpen nowQC Microbiology Specialist - Method Validation and NPIBioPharma Consulting JAD Group · Juncos, Puerto Rico

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  5. 38.3%30 days
  6. 59.0%60 days
This job: posted 6 hours ago

The posting

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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