Manufacturing Specialist

Flexible & Integrated Technical Services, LLC•Juncos, PR

1d•Onsite

About The Position

This role is within the Manufacturing Services area, specifically in Quality Systems. The ideal candidate will possess a blend of technical expertise and interpersonal skills, thriving in a dynamic, team-oriented environment that emphasizes the scientific method and ethical practices. The position involves hands-on work in a lab setting with access to necessary equipment, encouraging multitasking, scientific inquiry, and creative problem-solving.

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 a Manufacturing area, specifically writing procedures.
Experience managing documents in a document management system (document workflow).

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, evaluating, planning, and implementing solutions.
Provide troubleshooting support.
Assist in the generation of training materials and may 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 that 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.