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Manufacturing Compliance Specialist I/II
| Company | KBI Biopharma |
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| Location | Durham, NC, USA |
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| Salary | $63000 – $115500 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Mid Level, Senior |
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Requirements
- Experience in production or quality assurance of GMP manufacturing is required.
- Excellent written and verbal communication skills are required.
- Strong attention to detail, as well as, presentation, written, and verbal communication skills required.
- Energetic, motivated and dynamic individual.
- Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
- Specialist I: B.A./B.S. in a Life Sciences or Engineering degree and 2+ years relevant experience or HS Diploma and 6+ years of experience.
- Specialist II: B.A./B.S. in a Life Sciences or Engineering degree and 4+ years relevant experience or HS Diploma and 10+ years of experience.
Responsibilities
- Release electronic manufacturing records and logbooks. Perform reviews of electronic logbooks and manufacturing records. Prepare and track departmental manufacturing records and logbooks throughout entire lifecycle and support executed record reviews and comment resolution.
- Author, train, review manufacturing procedures.
- Oversee and execute against departmental compliance activities associated with QA Systems such as deviations, CAPAs, and change controls.
- Develop and oversee manufacturing training plan, and training compliance for department.
Preferred Qualifications
- Experience working with electronic quality management systems such as documentation, deviations, capas, and change control systems is preferred.
- Experience working with electronic manufacturing records or logbooks is preferred.
- Experience working in biopharmaceutical manufacturing is preferred.
