Job Title:
Quality Assurance Specialist
We are seeking a Quality Assurance Specialist to fill a critical role in our organization. The ideal candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
* Completes review and approval for CAPAs, change requests, investigative protocols, and final reports.
* Responsible for the quality aspects of material and supplier management, such as compilation of material qualification pack, supplier audit review, and supplier management system upkeep.
* Involved in the development and review of documentation and quality records in collaboration with other stakeholders.
* Review and approve GMP documentation/data for accuracy and completeness.
* Working cross-functionally to ensure project milestones are met in a timely manner.
Requirements:
* Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Engineering or Supply Chain in a relevant discipline.
* 5 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
* 2 years of experience in performing the release function in a regulated environment.
* Strong knowledge of qualification and implementation of single-use technologies and raw materials for use in a GMP environment.
* Proven track record in delivering excellence.