GMP Manufacturing Support I/II — Aseptic & Cleanroom

KBI Biopharma, Inc.

North Carolina

On-site

USD 52,000 - 76,000

Full time

8 days ago

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Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Support Associate I/II to support cGMP manufacturing. The role focuses on routine and non-routine cleanings of GMP facilities, process waste management, and ongoing operations support on a 12-hour shift.

Aseptic and gowning qualifications are required, and candidates must document and maintain records per regulatory requirements and SOPs. The position involves preparing processing assemblies (PAR), stocking supplies, and handling hazardous waste in

Qualifications

  • High school diploma or associate degree is required.
  • Aseptic and gowning qualifications are required.
  • Must be able to document and maintain records per regulatory requirements (cGMP, SOPs).
  • Experience with process waste handling is a plus.

Responsibilities

  • Performs and maintains manufacturing facilities by routine and non-routine cleanings (daily, weekly, monthly).
  • Cleans, operates, and maintains the Process Waste area; discards waste materials.
  • Prepares, builds, and completes processing assemblies (PAR) for production.
  • Completes facilities response forms and communicates EM sampling needs to other departments.
  • Stocks general supplies in the manufacturing production areas.
  • Handles and discards hazardous and nonhazardous waste.

Skills

Aseptic procedures
Gowning qualifications
Record/documentation
Waste management
Basic computer skills

Education

High School Diploma or Associate Degree

Tools

Word
Excel
Email

Job description

KBI Biopharma, Inc. is seeking a Manufacturing Support Associate I/II to support cGMP manufacturing. The role focuses on routine and non-routine cleanings of GMP facilities, process waste management, and ongoing operations support on a 12-hour shift.

Aseptic and gowning qualifications are required, and candidates must document and maintain records per regulatory requirements and SOPs. The position involves preparing processing assemblies (PAR), stocking supplies, and handling hazardous waste in

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