Job Overview
We are seeking a Data Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring the quality of data generated in support of batch release and stability programs.
Key Responsibilities:
1. Review data in a timely manner to ensure compliance with regulations and standards.
2. Utilize expertise in Empower to analyze results and identify deviations or lab investigations.
3. Trend data to identify patterns and anomalies.
4. Track and report Not Right First Time (NRFT) events.
5. Support the QC Laboratory and Management teams.
6. Collaborate with other departments to ensure smooth operations and communication.
7. Maintain and update control prints, methods, specifications, and SOPs in accordance with regulatory requirements.
8. Provide training and guidance to analysts on new methods, SOPs, and updates.
Requirements:
* Excellent Communication skills.
* Self-directed initiative to see issues through to completion.
* Ability to prioritize work and collaborate with the team.
* Extensive knowledge of cGMP and GDP in a regulated environment.
* Working knowledge of quality systems in a regulated environment.
* High accuracy and attention to detail.
* Strong interpersonal skills.