Change Control & Manufacturing Specialist

Flexible & Integrated Technical Services, LLC•Juncos, PR

13d•Onsite

About The Position

This role is within the Quality Systems area, specifically 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. Bilingualism in English and Spanish is required, along with project management skills. The position involves administrative tasks and is according to business needs. Experience with Veeva Vault (CDOCs), Smartsheet, technical writing, and change control is essential. The company fosters an environment of healthy competition, teamwork, ethics, and the use of the scientific method.

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 Veeva Vault (CDOCs)
Experience in Smartsheet
Experience in Technical writing
Experience in Change control

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 assist in providing 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.
Responsible for authoring investigation reports.
Responsible for the execution of corrective actions.
Responsible for managing NC/CAPA closure within the established goal.
Monitor and communicate incident trends.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.