Manufacturing Associate I/II – Support
| Company | KBI Biopharma |
|---|---|
| Location | Durham, NC, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Junior, Mid Level |
Requirements
- Manufacturing Associate I: High school diploma with 1-2 years’ of relevant experience.
- Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline with 0-2 years’ relevant experience; or high school diploma with 2-4 years’ relevant experience.
- 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.
- Extremely high attention to detail.
Responsibilities
- 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.
Preferred Qualifications
- Basic knowledge of cell culture or fermentation unit operation is preferred.
- Experience in single-use platform technology is preferred.
- Biowork certification with a High School Diploma.
- Experience in CDMO.