Website Lenox Executive Search
Lenox Executive Search is looking to fill a current opening for a Quality Assurance Specialist, with one of our global pharmaceutical clients. This is a contract position that has the potential to become permanent based on performance.
Key Duties and Responsibilities of a Quality Assurance Specialist:
- Performs analytical data review for commercial release and stability and verify documentation and determines acceptability by using standard operating procedures.
- Perform quality review/ approve of raw data and COAs in support of commercial batch release when needed.
- Upload the vendor created protocols in electronic document management system and update all commercial stability-controlled documents including Vendors Stability Protocols, Initiation Forms, and Data Tables. In addition, update JMP files for all commercial products if needed.
- Provide support to Clinical analytical data review as needed
- Support the day-to-day management of the analytical data from external CMO – Update trackers in a timely manner upon receipt of data from external vendors and follow up for any major delays or issues.
- Communicates proactively with internal and external partners and management.
- Assists department management with monthly/quarterly Quality System data review metrics and reporting
- Escalate critical and major finding to Quality management related to GXP Operational areas.
Knowledge and Skills of a Quality Assurance Specialist:
- Strong communication and influencing skills
- Ability to evaluate quality matters and make decisions utilizing risk-based approach
- Proficiency in using Microsoft Office applications
- Some experience with quality metrics, dashboards, analysis, and improvement programs
- Some experience with network-based applications such as Oracle, Veeva, etc
- Basic knowledge of current industry trends and regulatory requirements
Education and Experience of a Quality Assurance Specialist:
- Bachelor’s degree in relevant field is required
- Typically requires 2 years of experience or the equivalent combination of education and experience