As part of the Quality Team, the Senior Quality Assurance Specialist promotes and supports a culture of audit readiness. They are part of a team that collaborate with business partners to foster a high standard of regulatory compliance that contributes towards delivering actionable clinical insights that lead to therapies and treatments that provide health, healing and hope to patients around the world.
Qualifications & Experience
* Bachelor’s Degree in scientific discipline required or equivalent experience.
* Minimum 5 years’ experience in Quality Assurance, preferably within GCP Laboratory
* Knowledge of, and demonstrated experience with application of Good Clinical Practice (GCP) guidance is required
* Knowledge of, and demonstrated experience with application of, regulatory agencies Knowledge of applicable regulations and standards such as, ISO15189, NEQAS, CAP and CLIA is preferred
* Good organizational/time management skills
* Good written and verbal communication skills
* Analytical and problem solving skills
* Comfortable achieving results while working on multiple & divergent tasks
Responsible for performing the following duties:
* Ensure the Quality System is efficient for the business while maintaining compliance (Quality Issues, Change Controls, CAPAs, etc.).
* Ensure validation activities are appropriate and meet current industry requirements.
* Provide leadership and support of all external audits,
* Review and approve relevant documentation as required
* Provide appropriate QA consultation to ACM personnel.
* Lead and perform a wide range of activities to support the QA Department including quality improvement projects leading to a harmonized Quality Management System.
* Serve as a QA contact for customers as required.
* Provide consultation & interpretation of regulations, guidelines, corporate standards & policies.
* Participate in development and implementation of Quality training.
* Perform wide range of QA activities to support the quality program eg CAPAs, audits, change control, document reviews.
* Maintain current awareness of all required standards, laws & guidelines.
* Participate in Continuous Professional Development.
Accrediting Agency/Standards applicable to this role include (but not limited to):
International Council of Harmonisation Good Clinical Practice (ICH-GCP), New York State Department of Health (NYSDOH), College of American Pathologists (CAP), Food & Drug Administration (FDA), Medicine and Health Products Regulatory Agency (MHRA), Ministry of Health (MOH) Singapore, State Food & Drug Administration China (SFDA), European Medicine Agency (EMA) and other local state/country specific requirements as relevant to the position as identified by management
Product Quality Assurance
Good Clinical Practices (Gcp)
Complex Problem Solving