Quality Assurance Associate

1 day ago

Durham, North Carolina, United States Medasource Full time

Job Summary:

Medasource is seeking a Quality Assurance Associate to join our team in ensuring the quality of our products and services. The successful candidate will be responsible for performing a variety of duties associated with the Office of Regulatory Affairs and Quality, including release of products, assistance with deviations and event management, review of vendor qualifications, and analysis of environmental monitoring data.

Key Responsibilities:

  • Provide support and review of change control as it relates to development, modification, and manufacturing process changes.
  • Represent the Quality Department at project meetings and provide guidance.
  • Write, revise, and review SOPs.
  • Assist with continuous improvement projects and initiatives.
  • Track and trend metrics and identify areas of concern.
  • Assist in managing quality related matters during inspections.
  • Review and provide guidance for deviations and investigations.
  • Collaborate with end users about deviations, issues, and unexpected events that may arise.
  • Train staff on proper GMP, performing investigations, and root cause analysis.
  • Review product records for release.
  • Participate in multiple programs in varying phases of development or that require varying levels of QA involvement.
  • Conduct Environmental Monitoring of facilities and assist in data analysis.
  • Conduct audits under the supervision of the Lead Auditor and generate audit reports.

Requirements:

  • Bachelor's degree.
  • 5 years of experience in a GXMP or similar regulated environment.
  • Experience training users on implementing Quality Systems.
  • Prior laboratory experience preferred.
  • Experience in preparing for external audits and/or site visits.
  • Experience in reviewing raw materials, supplies, and manufactured products for acceptability.
  • A Master's or PhD can substitute for experience.
  • Proficient knowledge in GLP, GMP, and/or GTP.
  • Demonstrate leadership, organizational, and time management skills and the ability to handle a multitude of tasks.
  • Have ability to train other staff members effectively.
  • Attention to detail in document review.
  • Team player with sense of urgency to carry out tasks in a timely and accurate manner.
  • Ability to interact well with employees at all levels.
  • Strong organizational skills.
  • Excellent verbal, written, and interpersonal skills. Possess good problem-solving skills.
  • Adapt to changing priorities effectively.
  • Able to work effectively independently or in a team environment.

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