BioPharma Consulting JAD Group

QC Microbiology Specialist - Method Validation and NPI

BioPharma Consulting JAD Group  •  Juncos, PR (Onsite)  •  1 day ago
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Job Description

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)
BioPharma Consulting JAD Group

About BioPharma Consulting JAD Group

BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results.

Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields.

We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions.

BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.

Industry
Biotech & Life Sciences
Company Size
11-50 employees
Headquarters
Cambridge, MASSACHUSETTS
Year Founded
2010
Website
bpc-jadgroup.com
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