Process Development Associate

SGS Consulting; California City (CA); On-site; USD 52,000 - 76,000; Full time

Job summary

SGS Consulting in California City, CA is seeking a qualified candidate for a Laboratory Operations role. The incumbent will maintain the Pilot Plant laboratory under cGMP, produce development, pilot, and production materials, and complete ERP transactions per written instructions.

Responsibilities include maintaining records, meeting completion dates, preparing notebooks, and supporting process transfer and validation activities.

Qualifications

• Basic knowledge of QMS (Quality Management System)/GMP requirements.
• Must follow all applicable FDA regulations and ISO requirements.
• 1+ years’ experience preferred.

Responsibilities

• Maintain Pilot Plant laboratory under cGMP conditions.
• Produce development, pilot, and production materials per written instructions.
• Complete ERP transactions.
• Stock and maintain laboratory supplies.
• Keep accurate records and documentation.
• Complete laboratory work and associate paperwork by assigned completion dates.
• Produce notebook materials with written instructions.
• Develop manufacturing processes for transfer to Manufacturing.
• Assist with execution of process validation of new and existing manufacturing processes.
• Improve manufacturing processes.
• Completes cycle counts.
• Washes lab ware.

Skills

QMS/GMP knowledge

FDA/ISO compliance

Experience 1+ years

Education

Bachelor’s degree (sciences)

Job description

Job Responsibilities:

• Maintains the Pilot Plant laboratory under cGMP conditions.
• Produces development, pilot, and production materials per written instructions.
• Completes ERP transactions.
• Stocks and maintains the laboratory supplies.
• Keeps accurate records and documentation.
• Completes laboratory work and associate paperwork by assigned completion dates.
• Produces notebook materials with written instructions.
• Develop manufacturing processes for transfer to Manufacturing.
• Assists with execution of process validation of new and existing manufacturing processes.
• Improve manufacturing processes.
• Completes cycle counts.
• Washes lab ware.

Skills:

• Basic knowledge of QMS (Quality Management System)/GMP requirements
• Must follow all applicable FDA regulations and ISO requirements.
• 1+ years’ experience preferred

Education/Experience:

• Bachelor’s degree (sciences)