Manufacturing Compliance Specialist I/II
| Company | KBI Biopharma |
|---|---|
| Location | Durham, NC, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Junior, Mid Level |
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.
- 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.