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Manufacturing Support Associate I/II
2 months ago
Job Summary
KBI Biopharma is seeking a highly skilled Manufacturing Support Associate I/II to join our team. This role is responsible for the execution of production activities, including media and buffer preparation, within a Good Manufacturing Practice (GMP) environment.
Key Responsibilities
- Manufacture products per manufacturing batch records and in compliance with quality standards, company policies, and current regulations.
- Perform operations in a cleanroom environment, applying controls to ensure aseptic processing, including gowning and cleaning procedures.
- Document each task involving manufacturing procedures, following Good Documentation Practices (GDP), at the time of execution.
- Utilize and perform maintenance on equipment per applicable Standard Operating Procedures (SOPs).
- Ensure all items are issued and accounted for during the execution of a record.
- Demonstrate, apply, and ensure understanding of current Good Manufacturing Practices and how they apply to specific tasks and responsibilities.
- Participate and be accountable for room 5S.
Requirements
- High school diploma.
- Ability to follow written instructions.
- Excellent written and verbal communication skills.
- Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
- Energetic, motivated, and dynamic individual.
- Must have high attention to detail.
- Ability to work a 12-hour schedule, including weekends, nights, and holidays.
Preferred Qualifications
- Basic knowledge of cell culture or fermentation unit operations.
- Experience in single-use platform technology.
- Biowork certification.
- Experience in Contract Development and Manufacturing Organization (CDMO).
Compensation
KBI Biopharma offers a competitive salary and a robust total rewards strategy, including an annual bonus structure, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days, and employee recognition programs.
