Role OverviewThe GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities and supports new/existing project initiatives.
What You Will Do
Deliver Annual Product Quality Reviews (APQRs), coordinate with SMEs to develop APQRs, ensure CAPA actions are identified, and assist with executing and developing quarterly product quality trending.
Why It Might Be a Fit
This position requires experience with event investigations, Root Cause Analysis, and Veeva, as well as strong communication and collaboration skills.
Requirements
- Bachelor's degree in a scientific or allied health field
- Experience with event investigations (deviations), Root Cause Analysis (RCA), and CAPA
- Experience with network-based applications such as Veeva
- Knowledge of current industry trends and ability to use the latest technologies
- Experience supporting multiple projects/teams within stated objectives and timelines
- Experience supporting cross-functional team members and collaborate effectively
- Good communication skills (written and verbal) and the ability to exchange potentially complex information
- Ability to integrate activities with other groups, departments, and project teams as needed
- Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent
- Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
- Expanded conceptual knowledge of cGMP's in a pharmaceutical setting
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