Manufacturing Specialist- 10

Flexible & Integrated Technical Services, LLC•Juncos, PR

9d•Onsite

About The Position

This role is within the Quality Systems area for Manufacturing Services. The ideal candidate will have a Bachelor's Degree with five years of experience as a Scientist in the pharmaceutical or regulated industry. Bilingual in English and Spanish is required, along with strong Project Management skills. The position operates on an administrative shift, adaptable to business needs.

Requirements

Bachelor's Degree
Five (5) years of experience as a Scientist within the pharmaceutical or regulated industry
Bilingual (English & Spanish)
Project Management skills
Experience in Root Cause Analysis methodologies
Experience in Lean Manufacturing and GDP Practices
Experience with Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms

Responsibilities

Initiate, revise, and approve manufacturing procedures, ensuring they reflect current operations and serving as a document owner.
Assess process performance through observation of floor operations and review of performance data, then evaluate, plan, and implement solutions.
Provide troubleshooting support.
Assist in the generation of training materials and potentially provide training on scientific or technical aspects of the process.
Support the establishment of process monitoring parameters and control limits, collect process-monitoring data, and support the assessment of deviations.
Provide support for the timely execution of process monitoring quarterly reports.
Ensure all Non-conformances are triaged within the established goal.
Author investigation reports.
Execute corrective actions.
Manage NC/CAPA closure within the established goal.
Monitor and communicate incident trends.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.