Manufacturing Associate

Insight Global; Durham (NC); On-site; USD 42,000 - 54,000; Full time

Job summary

Insight Global in Durham, NC is seeking a Manufacturing Associate to execute Upstream production activities for cell culture programs within a GMP environment.

You will work on the manufacturing floor, preparing buffers and media, and following batch records while adhering to GMP, GDP, GLP and Right the First Time standards.

Experience in pharmaceutical manufacturing and aseptic processing is required.

Qualifications

• Experience within pharmaceutical manufacturing / GMP/ cGMP environment.
• Follows GMP, GDP and GLP; Right the First Time (RFT).

Responsibilities

• Perform operations in a cleanroom environment with aseptic controls.
• Manufacture cell culture products per batch records in compliance with quality standards.
• Comfortable working on the manufacturing floor.
• Prepare buffers, media, and product.

Skills

Aseptic processing

Gowning procedures

Cleanroom environment

Cell culture manufacturing

Tools

Batch records

GMP/GLP compliance

Job description

The Manufacturing Associate is responsible for the execution of Upstream production activities for early and late-phase Cell Culture programs within a GMP environment. Additionally, must ensure all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP); including ‘Right the First Time’ (RFT).

Responsibilities

• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.


• Manufacture cell culture products per manufacturing batch records in compliance with quality standards, company policies and current regulations.


• Comfortable working on manufacturing floor


• Preparing buffers, media, and product

Requirements

• Experience within pharmaceutical manufacturing / GMP/ cGMP environment