Manufacturing Specialist - Deviations and Investigations

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 55,000 - 83,000; Part time

Job summary

Biopharma-Consulting-Jad-Group seeks an experienced investigator to own deviations from triage through closure in a Puerto Rico drug substance operation. You will lead investigations, write reports, revise procedures, and support process monitoring.

The role requires GMP deviation experience, bioprocessing knowledge, and bilingual English/Spanish, with a 4-month contract and standard administrative hours.

Qualifications

• Bachelor's degree in manufacturing operations with 4+ years of experience
• GMP deviation/investigation experience required
• Bioprocessing unit operations, Lean, GDP knowledge
• TrackWise, Veeva, MES, CDOCS; Smartsheet and Power BI are a plus
• Bilingual English/Spanish

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

Deviation/investigation owner exp in G

Bioprocessing unit operations

Lean

GDP

Bilingual English/Spanish

Education

Bachelor's degree in manufacturing operations

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