Quality Assurance Specialist

6 days ago


Reston, Virginia, United States Aequor Full time
Job Summary

Aequor is seeking a highly skilled Quality Assurance Specialist to support our bioanalytical testing efforts. As a key member of our team, you will be responsible for ensuring the quality and integrity of our clinical and commercial products.

Key Responsibilities
  • Perform testing of in-process, final product, and stability samples to ensure compliance with regulatory guidelines.
  • Utilize scientific principles to develop and implement analytical testing methods and protocols.
  • Anticipate and troubleshoot problems to ensure timely completion of testing and release of products.
  • Recommend corrective actions and participate in the development of best practices to improve testing efficiency and accuracy.
  • Develop, write, and execute methods, protocols, reports, and other related documents to ensure compliance with regulatory requirements.
  • Complete all work in a timely manner and work effectively within the team to ensure timelines are met.
  • Perform peer review of testing data and review all data in accordance with applicable procedures and cGMP requirements.
  • Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
  • Train new analysts to general job duties and complete the necessary training to become a qualified trainer.
  • Support document revision, project, CAPA, and investigation/deviation-related tasks.
  • Draft and review technical documents, such as SOPs and protocols/reports.
  • Communicate effectively with management regarding task completion, roadblocks, and needs.
Requirements
  • Bachelor's degree in a science-related field.
  • 2-4 years of relevant work experience in a regulated environment.
  • Hands-on experience with various bioanalytical techniques, including ELISA, qPCR, and FACS.
  • Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
  • Technical writing skills.
  • Problem-solving ability/mentality, technically adept and logical.
  • Ability to represent the interests of the group on cross-functional teams.
  • Ability to set priorities for the group and manage timelines.
  • Ability to work with management locally and globally.
  • Ability to communicate effectively with peers, department management, and cross-functional peers.
Working Conditions

The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required. The incumbent must analyze numerical values on a daily basis. The incumbent will be working in a laboratory setting for up to six (6) hours per day. The incumbent will be working around biohazardous materials, including chemical agents, for up to six (6) hours per day.



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