We are currently seeking a Documentation Specialist for a prominent Pharmaceutical client of ours. This position is in Durham, NC. Details for the position are as follows:
Job Description:
Job Description:
- Pay: 28.83/hr.
- Length of Assignment: 6 months to start with potential for extension.
- 100 percent onsite position.
- Serve on the Manufacturing Support Team working with shop floor production personnel and interfacing with Technical Support and Quality Operations and must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation. The position requires great attention to detail, a command of good documentation practices (GDP) and the ability to design and strengthen documentation that satisfies Quality requirements.
- Provide documentation support for vaccine production activities.
- Review batch record, logbooks and electronic logbooks for errors and partner with Production, Quality and other personnel to correct such errors and provide clarification as needed.
- Support process documentation changes and improvements which includes updates to batch records and standard operating procedures (SOPs).
- Support process documentation deviation investigations to provide meaningful immediate and preventative actions and reduce the deviation generation rate.
- Working knowledge of cGMPs requirements.