Manufacturing Associate

Astrix Inc.; Holly Springs (NC); On-site; USD 25,000 - 28,000; Full time

Job summary

Astrix Inc. is seeking a Manufacturing Associate to join our team in Raleigh/Apex, NC, supporting GMP drug substance manufacturing and validation activities. This role focuses on manufacturing operations, compliance with GMP guidelines, and data analysis to optimize processes.

Contract to hire position offering growth opportunities. The successful candidate will contribute to continuous improvement, collaborate with cross-functional teams, and ensure high-quality manufacturing outcomes in a

Qualifications

• High School Diploma/GED with 4+ years relevant experience, or an associate/bachelor with related experience.
• Hands-on GMP/validation experience in drug substance manufacturing.
• Exposure to project management and process improvement initiatives.

Responsibilities

• Execute manufacturing operations on the production floor.
• Perform GMP and non-GMP production runs (small- and large-scale).
• Handle material preparation, equipment setup, and cleaning validation in GMP-compliant manner.
• Assist in process validation and technical support for manufacturing activities.
• Collect and analyze data related to manufacturing performance and validation.
• Support documentation processes, including batch records and deviation reports.
• Collaborate with Engineering, Process Development, and QA to optimize manufacturing workflows.
• Contribute to continuous improvement and best practices in drug substance manufacturing.

Skills

GMP knowledge

Data analysis

Documentation

Process improvement

Project management

Education

High School Diploma/GED + 4 years experience

Associate's Degree + 2 years experience

Bachelor's Degree + 6 months experience

Tools

Equipment setup

Cleaning validation

Job description

Pay Rate Low: 18.00 | Pay Rate High: 20.00

Our client, a renowned leader in biotechnology, is revolutionizing the use of living cells to create groundbreaking biologic medicines. As a guiding force in the biotech industry, they set the bar for innovation and advancement.

We are seeking a Manufacturing Associate to join our dynamic team and support GMP drug substance manufacturing and validation activities. This individual will play a crucial role in manufacturing operations, ensuring compliance with industry standards while contributing to process optimization and data analysis.

Location: Raleigh/Apex, NC

Contract to Hire

Pay: 18-20/hr.

If you are detail-oriented, eager to contribute to high-quality manufacturing processes, and excited about making an impact in the pharmaceutical industry

Key Responsibilities

• Execute manufacturing operations and support activities on the production floor.
• Perform GMP and non-GMP production runs (small- and large-scale).
• Handle material preparation, equipment setup, and cleaning validation in compliance with GMP guidelines.
• Assist in process validation and technical support for manufacturing activities.
• Collect and analyze data related to manufacturing performance and validation.
• Support documentation processes, including batch records and deviation reports.
• Collaborate with cross-functional teams (Engineering, Process Development, and Quality Assurance) to optimize manufacturing workflows.
• Contribute to continuous improvement efforts and best practices in drug substance manufacturing.

Education & Experience Options

• High School Diploma/GED + 4 years of relevant work experience
• Associate's Degree + 2 years of relevant work experience
• Bachelor's Degree + 6 months of relevant work experience

Required Skills

• Hands-on experience in GMP technical support, validation, engineering, or process development.
• Knowledge of drug substance manufacturing processes.
• Exposure to project management and process improvement initiatives.

Preferred Skills

• Experience with equipment and cleaning validation.
• Proficiency in data analysis and visualization tools.
• Strong technical writing skills for documenting manufacturing processes and validation reports.

Why Join Us?

• Opportunity to work on cutting-edge drug manufacturing processes.
• Hands-on experience in a regulated GMP environment.
• Collaborative, growth-focused team with opportunities for career advancement.