QC Specialist - Microbiology Deviations and Investigations

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 50,000 - 84,000; Part time

Job summary

BioPharma Consulting JAD Group is seeking a technical specialist in Juncos, Puerto Rico to own deviations in the Quality Control area and lead microbiology and analytical testing investigations. You will document investigations, provide technical guidance and support across groups, and ensure GMP/GLP compliance.

The role requires a microbiology background and experience with HPLC and analytical methods. Shift is administrative, Monday–Friday, for a 5.5-month contract with potential extension.

Qualifications

• Bachelor's degree with related experience or higher education equivalent.
• Experience with QC deviations and lab investigations in GMP environments.
• Strong knowledge of microbiology, HPLC and analytical methods.
• Excellent technical writing skills.

Responsibilities

• 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.

Skills

Microbiology

HPLC

Analytical methods

Technical writing

Education

Bachelor's degree

Master's degree

Associate's degree

High school diploma

Doctorate

Job 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.

• 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.

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