Under general guidance and direction, the Quality Assurance Manager provides professional level laboratory technical support involving the application of scientific research methods and techniques. He/she will report to the Biobank Facility Director in the UB Biobank Facility/Program (UB BB) and will participate as a team member in the codifying, updating, processing, and support of the UB BB quality system. UB BB plans to use a Quality Assurance (QA) management system (i.e Qualtrax) to document all Standard Operating Procedures (SOP), protocols, and policies. This position is responsible for ensuring all departments and employees are aware of and capable of following the regulatory standards implemented in this system.
Knowledge of the biobanking, bioprocessing, and analytics systems, especially experience with LIMS systems and QA software systems, used in the procedures and regulation of biomaterials is essential. Knowledge of GDP, GLP, GMP, RCA, CAPA and other regulatory standards and experience in a GMP regulated facility or pharmaceutical industry and with validation protocols is required. The position requires the employee to have excellent analytical and communication skills to facilitate efficient and accurate resolution plans, as well as, metrics reporting. Poor execution of resolution plans and metrics reporting could result in project delays, distribution of misidentified samples, reporting of erroneous data, and failure to identify trends which impact the quality of client services and products.
Specific Job Duties
• Policy Formulation and Implementation: Assists in the development and implementation of quality policies, procedures and processes of the quality system. Complies with and enforces GLP, GMP, CAP, CLIA, Industry Best Practices, and Quality Control procedures. Trains employees on quality initiatives. –
• Problem Resolution: Proactively tracks and facilitates the resolution and timely closure of internal and external client concerns. Provides support to investigators to ensure thorough and effective resolution. Assists UB BB departments in the investigation and resolution of non-conformances to ensure timely closure. Communicates substantial deviations from and concerns in meeting company standards and policies to the Quality Management team.
• Audit Participation: Assists in the preparation for audits and other audit related activities. Ensures timely closure of corrective actions resulting from audit findings through proactive tracking, monitoring and facilitation of the corrective action plan.
• Monitoring and Tracking: Reviews for compliance, monitors, tracks and maintains documents and records. Assists area Subject Matter Experts in the development and improvement of documentation to ensure consistency and compliance with company standards and policies. Provides user support for quality software system, quality control analysis and guidance with regulatory standards.
• Administration: Effectively communicates with departments and employees to build and maintain working relationships. Performs clerical duties, answers calls and correspondences in a timely manner. Keeps work area neat and clean. Completes other duties as assigned by the UB BB Director.