- Manufacture products according to batch records and quality standards, applying aseptic techniques and operating in a cleanroom environment.
- Document manufacturing procedures accurately and perform equipment maintenance.
- Adhere to Good Manufacturing Practices, maintain 5S in the production area, and be accountable for issued items.
- High school diploma.
- Ability to follow written instructions.
- Strong written and verbal communication skills.
- Organized, efficient, and detail-oriented individual.
- Ability to work weekends, nights, and holidays.
- Basic knowledge of cell culture or fermentation unit operations.
- Experience in single-use platform technology.
- Biowork certification.
- Experience in CDMO.
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Manufacturing Associate I/II
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Associate II, Quality Assurance Biologics
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Manufacturing Support Associate I/II - Durham, United States - KBI BioPharma
Description
**Position Summary**
This position for MFG Support Associate I/II involves executing production activities related to Media and Buffer preparation within a GMP environment. The role requires adherence to instructions in SR's, SOP's, and forms while ensuring compliance with GMP, GDP, and GLP standards. Ideal candidates will take ownership of production processes, including raw material dispensing, media/buffer preparation, and equipment operation. Troubleshooting skills are essential for improving daily operations in media/buffer formulation. Key responsibilities include maintaining production standards, performing CIP procedures, and ensuring operational efficiency.
**Position Responsibilities**
KBI Biopharma, Inc. is dedicated to maintaining a safe workplace and encourages diversity in its workforce. Qualified applicants from all backgrounds are encouraged to apply.
**About KBI Biopharma, Inc.**
Thank you for considering a career at KBI Biopharma, Inc. Please note that completion of this application does not guarantee employment. Both parties retain the right to terminate employment at any time, for any reason. By submitting this application, I confirm that all information provided is accurate and authorize reference checks.
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