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- Data review of ongoing testing, spreadsheets, electronic notebooks, Empower or other software to ensure compliance to cGMP standards.
- Expert knowledge of regulations and legal requirements as well as policies and procedures as relevant to areas of responsibility.
- Review the materials management system for inventory use verification.
- Works closely with other departments and Quality Assurance staff to develop, define and document project requirements.
- Understands, communicates and incorporates organizational knowledge and objectives into daily work processes.
- Utilizes verbal and written communication strategies to effectively create and relay messages on quality assurance processes, methods and tools.
- Lead projects in continuous improvements in a quality assurance environment to detect issues and ensure requirements are met prior to release of information to clients.
- Creation and maintenance of detailed technical documentation according to stated objectives.
- Resolve any documentation discrepancies related to assigned tasks.
- File and archive documentation.
- Mentor junior QA staff members.
- Performs other duties as requested.
Company Description:Prompt Praxis Laboratories, LLC, founded in 2011, is a women-owned fully-integrated laboratory powered with the current information technology to facilitate rapid drug testing or development. The emphasis on automation of critical laboratory processes allows PPL to minimize human error within the testing and analysis process.
Prompt Praxis Laboratories provides a full range of rapid testing and support services focusing on pharmaceutical products and compounded sterile or nonsterile preparations. Our support activities span three major industries: