Associate Manufacturing Operations

Bespoke Pharmaceuticals LLC; Las Vegas (NV); On-site; USD 30,000 - 50,000; Full time

Job summary

Bespoke Pharmaceuticals LLC in Las Vegas is hiring for a crucial role focusing on GMP compliance and production processes. The position requires maintaining high standards in cleanliness and safety while operating production equipment.

With a focus on quality control, candidates should have knowledge of FDA regulations and document management. The role emphasizes training in GMP and ensuring product sterility and quality, making it essential to have a detail-oriented mindset.

Qualifications

• Minimum of 0 years experience, 2 years preferred.
• Knowledge of GMP, FDA regulations, and data integrity principles required.
• Training in GMP basics and data integrity basics needed.

Responsibilities

• Maintain a clean, organized, and safe work environment.
• Document processes and batch records in compliance with regulations.
• Operate and monitor production equipment.

Skills

GMP fundamentals

Aseptic technique

Quality control checks

Computer Literacy

Education

High School diploma or Associate's degree or Bachelor's degree

Tools

ERP systems

Electronic document management systems

Microsoft Office Suite

Job description

Job Description

Responsibilities

• GMP fundamentals, Aseptic technique, qualified gowning and cleanroom behavior.
• Maintaining a clean, organized, and safe work environment (including cleaning/disinfecting equipment pre-use and post-use).
• Performing quality control checks, troubleshooting minor issues, and reporting deviations or problems to supervisors.
• Documenting processes, batch records, or data in compliance with regulations.
• Supporting process improvements, training runs, validation activities, or continuous improvement efforts.
• Operating and monitoring production equipment/machines (e.g., bioreactors, assembly lines, filling machines, or packaging systems).
• Setting up workstations, preparing raw materials, staging components, and verifying inventory/supplies.
• Assembling, producing, inspecting, testing, and packaging products according to standard operating procedures (SOPs).
• Executes manufacturing steps that directly impact product sterility and quality.

Skills & Experience

• Education: HS AA or BS
• Minimum Experience: 0 years
• Preferred Experience: 2 years
• Required Credentials: None
• Required Training: GMP basics, data integrity basics
• Knowledge of GMP, FDA regulatory expectations, data integrity (ALCOA), and applicable ICH/GxP principles.
• Computer Literacy: ERP systems, electronic document management systems, Microsoft Office Suite.