Quality Assurance Specialist
As a part of the Quality Assurance team, the Quality Assurance Specialist promotes and supports a culture of audit readiness within ACM Global Laboratories. Responsible for hosting customer audits & regulatory inspections, conducting internal audits, managing Quality Issue (QI) tracking, manages Corrective Actions & Preventive Actions (CAPA) and develops and maintains Standard Operating Procedures (SOPs). The Quality Assurance Specialist reports to the Director, Quality Assurance for our Rochester, NY site.
STATUS: Full Time
LOCATION: 160 Elmgrove Road, Rochester NY
DEPARTMENT: Quality Assurance
SCHEDULE: Monday - Friday
- Bachelor’s degree required.
- 3 years of quality assurance experience required; experience in a laboratory, pharmaceutical or Clinical Research Organization (CRO) preferred.
- Knowledge of and demonstrated experience in Good Clinical Practice (GCP), ISO15189, NEQAS, CAP, CLIA strongly preferred.
- Quality Assurance. Manage internal/external audits and regulatory inspections; support QI tracking and CAPA plans.
- Process Improvement. Support the operation in process improvement initiatives; develop Standard Operating Procedures (SOPs) to support the QMS.
- Training. Maintain keen knowledge of Good Clinical Practice (GCP) and appropriate regulatory standards to train and support the operation.