Quality Assurance Specialist

4 weeks ago


San Diego, California, United States Alimentiv Full time

Responsible for providing senior support in planning, organizing and/or evaluating the day-to-day delivery of global quality assurance (QA) services for Alimentiv Holdings companies. Responsible for supporting the businesses in quality assurance, policy planning and development, ongoing quality improvement through clinical and/or laboratory audit and liaison with other business units and external partners. Will also provide support, expertise, and industry best practice guidance.

Quality Assurance Implementation

  • Implement quality assurance plans and processes and identify indicators needed to assess product/service quality levels.
  • Collaborating with management/functional experts or Sponsors to identify requirements of the organization in order to conduct internal audits, site audits, vendor assessments and vendor audits.
  • Oversee the development of Quality System documents including policy, procedure, instruction, guidance and form and template development in collaboration with departments and senior management.
  • Develop QA processes, train and oversee junior QA staff.
  • Liaise with the Human Resources department and/or other stakeholders to ensure that all staff are qualified.
  • Remain current on and ensure internal awareness of regulatory trial and/or laboratory conduct standards, requirements, and accreditations (e.g., CAP/CLIA) including local requirements as applicable.
  • Identify changes to standards and regulations governing Clinical Laboratories and/or Clinical Research and provide recommendations for implementation as required.

Regulatory, Ethical, and Audit Monitoring

  • Remain current on, interpret and communicate changes to regulatory trial and/or laboratory conduct standards and requirements.
  • Identify, implement and/or develop policies, processes, and/or training to meet these standards.
  • Plan/lead/facilitate Sponsor and regulatory inspections, certifications and audit activities including preparation of staff, oversight of proceedings and ensure findings addressed are resolved.
  • Perform internal audits and vendor audits, ensuring that all observations are appropriately addressed and resolved.
  • Communicate audit findings to internal stakeholders and provide guidance to teams regarding the development of Root Cause Analysis and Corrective Preventive Actions.
  • Liaise with other departments in the completion of Sponsor requests for information.
  • Support internal departments with privacy related questions or inquiries.

Product/Service Consulting

  • Provide guidance during product/service enhancements cycles or during times of organizational change around quality compliance and cross-functional process requirements and organization efficiency gains.

Qualifications

  • The successful candidate will possess either an undergraduate or Master's degree with a minimum of 4-6 years of related experience.
  • Life Sciences, Clinical Research, Information Technology, Laboratory Science or Clinical Quality Assurance specialty preferred.
  • Demonstrated knowledge and experience in Clinical Quality and/or a Clinical (Pathology) Laboratory preferred
  • Strong analytical, critical thinking and problem-solving skills.
  • Knowledge of ICH GCP and GLCP global regulations governing Clinical Research and or laboratory research and global privacy regulations.
  • Proficient in the use of Quality Management Systems.


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