- Manufacture products per manufacturing batch records and in compliance with quality standards, company policies and current regulations. The duties required include, but are not limited to, aseptic techniques for cell culture feeding, expansion and counting.
- Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
- Document each task involving manufacturing procedures (i.e. SR's, EPR's and BR's) following GDP at the time of execution.
- Utilize and perform maintenance on equipment per applicable SOP.
- Ensure all items are issued and accounted for during the execution of a record (i.e. SR, EPR and BR).
- 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.
- 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 to include 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 Support Associate I/II- Days - Durham, United States - KBI Biopharma
Description
Position Summary
This position is on 2-2-3 shifts, 7a-7p. MFG Support Associate I/II is responsible for the execution of production activities of Media and Buffer preparation within a GMP environment.
The Manufacturing Associate I/II – Support must follow the instructions depicted in SR's (Media / Buffer Solution Records), SOP's and forms. Additionally, must ensure all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP); including 'Right the First Time' (RFT).
The ideal candidate will maintain a sense of ownership of the production processes, manufacturing environment and facility in activities such as dispensing raw materials, utilizing analytical scales, preparing media/buffers using various equipment like formation tanks/vessels/sum's, assembly preparation, parts washing, and autoclaving. This role focuses on providing crucial manufacturing support operations and requires a deep understanding of the fundamentals, as well as practical skills in the formulation of media's/ Buffers using stainless tanks / vessels / Sums including the use of single -use bags with mixers.
Manufacturing Support operations fundamentals, utilize knowledge and prior experiences to troubleshoot, and continuously enhance the daily manufacturing operation in the formulation of Media's/Buffers, leveraging your expertise with Stainless steel tanks / Vessels / Sums and the utilization of single-use bags with Mixers. Perform clean-in-place (CIP) procedures for tanks and auxiliary equipment, such as Transfer pumps, Crimpers, Tubing welders and sealers, pH/Conductivity meters, and Filter Integrity Testers.
Position Responsibilities
Minimum Requirements
Preferred Qualifications
Salary: $ /hour
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.
