Manufacturing Specialist - Deviations and Investigations
BioPharma Consulting JAD Group
Job Description
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.
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
Vacancy posted 1 day ago
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