Senior Quality Assurance Specialist
As a part of the Quality Assurance team, the Sr. Quality Assurance (QA) Specialist promotes and supports a culture of audit readiness within ACM Global Laboratories. The Sr. QA Specialist is responsible for the development, implementation and on-going continuous improvement of the site’s Quality Systems. This position supports vendor qualifications, and hosts and conducts audits (e.g., customer, internal, vendor and regulatory inspections). The Sr. QA Specialist effectively conducts and supports Quality Issues (QI) and manages Corrective Actions & Preventive Actions (CAPA) and Change Controls (CC). This position is responsible for developing/maintaining Quality System Standard Operating Procedures (SOPs) and performing the QA review/approval of the site’s SOPs and a wide variety of Good Clinical Practice (GCP) related documents, including laboratory equipment and method validations/analytical reports. In addition, the Sr. QA Specialist serves as a frequent inter-organizational contact and represents the department on project teams, as well as provides leadership to the site for GCP related training. The position also supports generation and reporting of Key Quality Performance Indicators for the site’s Quality Systems.
STATUS: Full Time
LOCATION: 160 Elmgrove Road, Rochester NY
DEPARTMENT: Quality Assurance
SCHEDULE: Monday - Friday
- Bachelor’s degree preferred.
- Minimum 5 years of quality assurance experience required.
- Experience in a laboratory, pharmaceutical or Clinical Research Organization (CRO) preferred.
- Knowledge of and demonstrated experience in GCP, ISO15189, NEQAS, CAP, CLIA strongly preferred.
- Certified Quality Auditor preferred.
- Quality Assurance. Ensure the Quality System/personnel is efficient for the business while maintaining compliance (Quality Issues, Change Controls, CAPAs. Lead the development and implementation of Quality Improvement projects. Participate and function as the QA Compliance leader on site project team. Ensure validation activities are appropriate and meet current industry requirements. Provide leadership and support of all external audits, including organization of departments to ensure a smooth audit process, and coordination of audit responses and follow up actions resulting from audit findings.
- Process Improvement.Review and approve documentation such as procedures, protocols, and reports as required by US, UK, European and applicable Rest of World (ROW) regulations. Provide appropriate QA consultation to ACM personnel.Consultation must meet current regulatory requirements and be appropriate for the business.
- Training. Maintain keen knowledge of Good Clinical Practice (GCP) and appropriate regulatory standards to train and support the operation. Serve as a resource promoting the development and understanding of the key elements related to Quality Management Systems & regulatory compliance requirements. Identify and develop Quality training strategy for the organization.