BioPharma Consulting JAD Group

Advises drugmakers on engineering and compliance

QC Specialist - Microbiology Deviations and Investigations

Regulatory & Quality (Life Sciences)Posted on Nov 13

Full-timeJuncos, Puerto RicoNo salary listed

About the Job

Requirements

A bachelor's degree and 4 years of directly related experience, a master's degree and 2 years, an associate's degree and 8 years, a high school diploma and 10 years, or a doctorate is required.
Experience with QC deviations and laboratory investigations in a GMP environment is required.
Knowledge of microbiology, HPLC, and analytical methods is required.
Strong knowledge of GMPs and CFRs is required.
Technical writing skills are required.

Responsibilities

Own deviations in the Quality Control area as the technical specialist for microbiology and analytical testing.
Lead and document QC deviations and laboratory investigations, including root cause analysis and CAPA.
Provide technical guidance, data analysis, and reports across technical groups.
Resolve technical issues and troubleshoot microbiology assays, HPLC, and analytical methods.
Develop, revise, and audit controlled documents.
Support laboratory GMP/GLP compliance and audits.

Desired Qualifications

A microbiology background is preferred.
Bilingual English and Spanish is preferred.

QC Specialist - Microbiology Deviations and Investigations

BioPharma Consulting JAD Group · Juncos, Puerto Rico · Contract · Posted 2026-11-13

Workplace: on_site

Department: Amgen

Description

Own deviations in the Quality Control area at a leading biotechnology company in Juncos, Puerto Rico, as the technical specialist for microbiology and analytical testing.

What you'll do

Lead and document QC deviations and lab investigations, including root cause and CAPA.
Provide technical guidance, data analysis and reports across technical groups.
Resolve technical issues and troubleshoot assays (microbiology, HPLC and analytical methods).
Develop, revise and audit controlled documents; support lab GMP/GLP compliance and audits.

Requirements

Bachelor's + 4 years (or Master's + 2, Associate's + 8, High School + 10, or a Doctorate) of directly related experience; microbiology background preferred.
QC deviations and laboratory investigations in a GMP environment.
Microbiology, HPLC and analytical methods.
Strong knowledge of GMPs/CFRs; excellent technical writing.
Bilingual English/Spanish preferred.

Benefits

Contract: 5.5 months, with possible extension
Shift: Administrative, Monday–Friday

Apply

Apply at BioPharma Consulting JAD Group

About the Company

BioPharma Consulting JAD Group

Advises drugmakers on engineering and compliance

BioPharma Consulting JAD Group advises pharmaceutical and biotechnology businesses on engineering, quality and regulatory compliance. It works with companies operating under US Food and Drug Administration rules to develop technical solutions for their manufacturing plants and processes. Its engineering practice covers facility and equipment design, process improvements and project management, while validation work verifies and documents that production systems meet requirements. The firm sells tailored consulting and technical support for assignments and projects, with company managers involved in delivery. Founded in 2010, it is headquartered in Cambridge, Massachusetts.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: Cambridge, MA
Founded: 2010

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