Manufacturing Specialist - Deviations and Investigations

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

BioPharma Consulting JAD Group is seeking a candidate to own deviations from triage to closure in a drug substance operation in Juncos, Puerto Rico. The role requires leading investigations and delivering timely closure with strong RCA skills.

Responsibilities include revising procedures, supporting process monitoring, change controls, and new product introductions. Bilingual English/Spanish is required, with shift Monday–Friday, 8:00 am–5:00 pm, start immediately.

Qualifications

• Bachelor's degree + 4 years (or Associate's + 8, or High School + 10) in manufacturing operations.
• Deviation/investigation owner experience in GMP manufacturing (required).
• Bioprocessing unit operations, Lean, GDP.
• TrackWise, Veeva, MES, CDOCS; Smartsheet and Power BI are a plus.

Responsibilities

• Own nonconformances: triage, investigation, root cause, CAPA and on-time closure.
• Use RCA tools (Fishbone, 5 Whys, Kepner-Tregoe) and write clear investigation reports.
• Revise manufacturing procedures and support process monitoring.
• Support change controls and new product introductions.

Skills

Root cause analysis

Investigation leadership

GMP manufacturing

Bilingual English/Spanish

Education

Bachelor's degree in manufacturing operations

Associate's degree in manufacturing operations

High School diploma

Tools

TrackWise

Veeva

MES

CDOCS

Smartsheet

Power BI

Job description

Own manufacturing deviations from triage to closure in a drug substance operation at a leading biotechnology company in Juncos, Puerto Rico. This role is for people who have led investigations themselves, not only supported them.

What you'll do

• Own nonconformances: triage, investigation, root cause, CAPA and on-time closure.
• Use RCA tools (Fishbone, 5 Whys, Kepner-Tregoe) and write clear investigation reports.
• Revise manufacturing procedures and support process monitoring.
• Support change controls and new product introductions.

• Bachelor's degree + 4 years (or Associate's + 8, or High School + 10) in manufacturing operations.
• Deviation/investigation owner experience in GMP manufacturing (required).
• Bioprocessing unit operations, Lean, GDP.
• TrackWise, Veeva, MES, CDOCS; Smartsheet and Power BI are a plus.
• Bilingual English/Spanish.

• Contract: 4 months, with possible extension
• Shift: Administrative, Monday–Friday 8:00 am–5:00 pm (overtime as needed)
• Start: Immediate