Senior Quality Assurance Specialist
Company: Rochester General Health System
Posted on: June 8, 2021
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
STATUS: Full Time
LOCATION: Remote (United States)
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.
Keywords: Rochester General Health System, Rochester , Senior Quality Assurance Specialist, Other , Rochester, New York
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