Associate Manufacturing Operations

Bespoke Pharmaceuticals LLC; Nevada (IA); On-site; USD 36,000 - 54,000; Full time

Job summary

Bespoke Pharmaceuticals LLC is seeking a Manufacturing Technician to perform GMP-compliant production tasks, maintain cleanroom standards, and support QC activities. The role involves documenting batch records and ensuring regulatory adherence in a fast-paced facility.

Ideal candidates have HS/AA/BS education, basic GMP training, and familiarity with ERP systems and data integrity concepts. Experience is beneficial but not required.

Qualifications

• GMP basics training is required.
• Data integrity basics training is required.
• Knowledge of GMP, FDA expectations, data integrity (ALCOA) and GxP principles.
• Experience with ERP and electronic document management systems.

Responsibilities

• Apply GMP, aseptic technique, gowning and cleanroom behavior.
• Maintain a clean, organized, and safe work environment.
• Perform quality control checks, troubleshoot issues, and report deviations or problems to supervisors.
• Document processes, batch records, or data per regulations.
• Support process improvements, training runs, validation activities, or CI efforts.
• Operate and monitor production equipment (e.g., bioreactors, filling machines, packaging systems).
• Set up workstations, prepare raw materials, stage components, verify inventory.
• Assemble, produce, inspect, test, and package products per SOPs.
• Execute manufacturing steps that impact sterility and quality.

Skills

GMP fundamentals

Aseptic technique

Documentation & recordkeeping

Data integrity (ALCOA)

Regulatory compliance

Troubleshooting

Education

HS/AA/BS

Tools

ERP systems

Electronic document management

Microsoft Office

Job description

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.