Manufacturing Specialist - Deviations and Investigations
BioPharma Consulting JAD Group
•Onsite
About The Position
Own manufacturing deviations from triage through closure in a drug substance operation at a leading biotechnology company in Juncos, Puerto Rico. This role is intended for candidates who have personally led investigations, rather than only supported them. The position is a four-month contract with a possible extension. The schedule is administrative, Monday through Friday, 8:00 a.m. to 5:00 p.m., with overtime as needed. The start is immediate.
Requirements
- Bachelor's degree and 4 years of experience in manufacturing operations, or an Associate's degree and 8 years of experience, or a high school diploma and 10 years of experience.
- Experience owning deviations and investigations in GMP manufacturing.
- Experience with bioprocessing unit operations, Lean, and GDP.
- Bilingual in English and Spanish.
- Experience with TrackWise, Veeva, MES, and CDOCS.
Nice To Haves
- Experience with Smartsheet and Power BI.
Responsibilities
- Own nonconformances from triage through investigation, root cause determination, CAPA, and on-time closure.
- Use root cause analysis tools, including Fishbone, 5 Whys, and Kepner-Tregoe, and write clear investigation reports.
- Revise manufacturing procedures and support process monitoring.
- Support change controls and new product introductions.
