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Quality Assurance Assistant

2 months ago

Franklin Township, United States J & J Staffing Resources Full time

Our client, located in Somerset, NJ, is looking to add a Quality Assurance Assistant to their team. The Quality Assurance Assistant will be responsible for overseeing the development and implementation of clinical software applications, training programs, and internal and external audits.


This is full-time, direct hire, in person position.


Schedule: Monday through Friday, 9:00AM-5:00PM.


Salary: $50,000/year.


Responsibilities:

  • Write new Standard Operating Procedures based on regulatory requirements, industry best practices, and internal processes.
  • Ensure that SOPs are clear, comprehensive, and practical for implementation. Regularly review existing SOPs to ensure they remain current and compliant with any changes in regulations or internal practices.
  • Make necessary updates and revisions to SOPs in collaboration with relevant stakeholders.
  • Perform comprehensive internal and external audits including vendor audits, document audits, and process audits to ensure compliance with GCP, SOPs, and regulatory requirements.
  • Document audit findings, prepare detailed reports, and communicate findings to relevant stakeholders. Follow up on findings to ensure corrective actions are implemented.
  • Develop, implement, and monitor CAPAs based on audit findings and quality incidents. Ensure timely resolution and effective preventative measures.
  • Train clinical staff on QA processes, GCP, and regulatory requirements. Develop and deliver training materials and sessions.
  • Assist in the preparation for and conduct of regulatory inspections by the FDA, EMA, and other international agencies. Provide support during inspections and follow-up activities.
  • Maintain accurate and complete documentation of all QA activities, audits, and training sessions. Ensure records are kept in accordance with company policies and regulatory requirements.

Qualifications:

  • Bachelor’s degree.
  • 1-4 years of work experience in quality assurance, clinical research, or a related field.
  • Strong understanding of software development lifecycle, software testing methodologies, and validation principles.
  • Ability to work both independently and collaboratively in a fast-paced, team environment.
  • Ability to prioritize workload while meeting multiple requests and deadlines in a consistent and timely manner.
  • Excellent organizational skills and attention to detail.
  • Excellent written and verbal communication skills.