Pharma Manufacturing Quality Systems Specialist

FITS LLC; Juncos (PR); Hybrid; USD 85,000 - 110,000; Full time

Job summary

FITS LLC in Puerto Rico/US seeks a qualified Scientist for Manufacturing Services within Quality Systems. The role requires a Bachelor's Degree with four years of experience in the pharmaceutical or regulated industry, and bilingual English/Spanish communication.

You will initiate, revise, and approve manufacturing procedures, assess process performance, provide troubleshooting, and support CAPA investigations, NC closures, and quarterly monitoring reports.

Qualifications

• Bachelor's Degree with four years of experience as a Scientist in the pharmaceutical or regulated industry.
• Bilingual English & Spanish.
• Experience in Change Control processes, TrackWise and SAP.
• Experience with Non-conformance/CAPA investigations and closure management.
• Experience with process validation protocols, execution, and data analysis.

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.

Skills

Bilingual English/Spanish

Project Management

Change Control

NC/CAPA Investigations

Process Validation & Data Analysis

Education

Bachelor's Degree

Tools

TrackWise

SAP

Job description

FITS LLC in Puerto Rico/US seeks a qualified Scientist for Manufacturing Services within Quality Systems. The role requires a Bachelor's Degree with four years of experience in the pharmaceutical or regulated industry, and bilingual English/Spanish communication.

You will initiate, revise, and approve manufacturing procedures, assess process performance, provide troubleshooting, and support CAPA investigations, NC closures, and quarterly monitoring reports.