JT878 - MANUFACTURING PROCESS TECHNICIAN - NS

Quality Consulting Group • New Albany, OH

1d

About The Position

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Requirements

• Bachelor’s degree in Life Science and/or Engineering
• 1-3 year of experience in manufacturing preferably in a FDA regulated environment.
• Mechanical ability/expertise.
• Understand equipment/processes.
• Technical writing capability.
• Ability to interpret and apply GMP concepts.
• Understand analytical methods for manufacturing area.
• Basic project management skills.

Responsibilities

• Performs manufacturing processes according to Standard Operating Procedures.
• Operating high speed packaging equipment
• Must be proficient at Associate Manufacturing and may perform those functions in addition.
• Perform initial review of manufacturing procedures/batch records.
• Draft and revise more complex documents (e.g. MPs, SOPs, technical reports, validation documents, investigation reports, etc.)
• Audit critical records.
• Propose corrective action for Quality incidents.
• Assist & plan improvement implementation related to routine functions.
• Interact with other departments to implement planned improvements.
• Identify and propose solutions to complex problems.
• Perform data analysis (e.g., SPC, CPV) of critical process parameters.
• Lead capacity for equipment/process operations.
• May perform system owner responsibilities (i.e., process, document).
• Supports manufacturing procedures (and other related documentation) generation and review process.
• Troubleshoots process and assesses process performance thru process monitoring.
• Supports NC CAPA process by completing process assessments and participating in cross functional investigational teams, defining and implementing CAPAs and reporting incident trending.
• Assists in the generation, review and execution of process validation protocols.
• Supports new product introduction and product life cycle.
• Initiates and Implement Level 1 and Level 2 Change Control records.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees