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Production Support Specialist I/II
2 months ago
Position Overview
The role of Production Support Specialist I/II focuses on executing manufacturing tasks related to Media and Buffer preparation within a regulated environment. This position necessitates strict adherence to established protocols in Standard Operating Procedures (SOPs) and documentation while ensuring compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP). Candidates who excel in this role will demonstrate a proactive approach to production processes, including the dispensing of raw materials, preparation of media and buffers, and operation of equipment. Effective troubleshooting skills are crucial for enhancing daily operations in media and buffer formulation. Key responsibilities encompass maintaining production quality standards, executing Cleaning in Place (CIP) procedures, and ensuring operational efficiency.
Key Responsibilities
- Produce products in accordance with batch records and quality specifications, utilizing aseptic techniques and working within a cleanroom setting.
- Accurately document manufacturing processes and perform routine equipment maintenance.
- Comply with Good Manufacturing Practices, uphold a 5S standard in the production area, and manage issued materials responsibly.
- High school diploma or equivalent.
- Ability to follow detailed written instructions.
- Strong communication skills, both written and verbal.
- Highly organized, efficient, and detail-oriented.
- Willingness to work during weekends, nights, and holidays.
- Basic understanding of cell culture or fermentation processes.
- Experience with single-use technology platforms.
- Certification in biowork.
- Background in Contract Development and Manufacturing Organizations (CDMO).
KBI Biopharma, Inc. is committed to fostering a safe work environment and promoting diversity within its workforce. We encourage qualified candidates from all backgrounds to consider applying.
About KBI Biopharma, Inc.
We appreciate your interest in a career with KBI Biopharma, Inc. Please be aware that submitting this application does not guarantee employment. Both the employer and employee retain the right to terminate employment at any time, for any reason. By submitting this application, you confirm that all information provided is accurate and authorize reference checks.
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