Manufacturing Specialist- 04

Flexible & Integrated Technical Services, LLC•Juncos, PR

7d•Onsite

About The Position

This role is within the Quality Systems area of Manufacturing Services. The ideal candidate will possess strong technical and interpersonal skills, with a background in the pharmaceutical or regulated industry. The position involves assessing process performance, troubleshooting, supporting process monitoring, and managing non-conformances and corrective actions.

Requirements

Bachelor's Degree with five (5) years of experience as a Scientist within the pharmaceutical or regulated industry.
Bilingual (English & Spanish).
Project Management skills.
Experience in Deviations/non-conformances investigations.
Experience in Technical writing and development of reports.
Experience in Root cause analysis tools (e.g. causal factors analysis, 5 Why’s).
Experience in Identifying/tracking actions and achieving due dates.

Responsibilities

Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions.
Provide troubleshooting support.
Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
Provide support of timely execution of the process monitoring quarterly reports.
Ensure that all Non-conformances are triaged within the established goal.
Responsible for authoring investigation reports.
Responsible for execution of corrective actions.
Responsible for managing NC/CAPA closure within established goal.
Monitor and communicate incidents trends.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.