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Open nowPosted 3 days ago

Manufacturing Specialist - Deviations and Investigations

BioPharma Consulting JAD Group

Where
Juncos, Puerto Rico
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Your applicationOpen nowManufacturing Specialist - Deviations and InvestigationsBioPharma Consulting JAD Group · Juncos, Puerto Rico

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  4. 19.7%14 days
  5. 35.6%30 days
  6. 58.0%60 days
This job: posted 3 days ago

The posting

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.

Requirements

  • 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.

Benefits

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