Quality Assurance Specialist, Client Services
This position reports to the Quality Assurance Manager. Responsible to perform Quality Assurance activities in support of Quality Systems and/or client procedures including but not limited to client specific document management, issuance, investigation, CAPA, creating/updating SOPs, Qualification and Validation Reports, etc. Attends project kick off meeting, as well as weekly project meeting. Participate in to tech transfer activity. Represent quality department during client meetings. Work with trifunctional department to ensure project related activity is completed on time. This role supports internal and external audits which may include interaction with Health Authorities and clients.
Essential Functions and Responsibilities
Attends project kick-off meetings to understand the scope of the project.
Creates, updates, reviews and/or approves project related documents such SOPs, Batch release templates, label templates, batch records, change controls, etc. according to client requirements and project scope.
Participates in tech transfer activity to ensure adherence to quality system standards.
Proactively identifies risk and prepares mitigation strategies associated with project and client work.
Represents QA Client Services during scheduled meetings with client and cross functional department.
Ensures all necessary quality documents are closed prior to batch released; responsible for batch released on timely manner according to schedule. .
Participates in client meetings and monitor quality activities of internal team members as they relate to contract deliverables.
Draft initial Quality agreement and complete necessary revisions based on client and company requirements
Promptly and effectively communicates any successes, challenges, and/or constraints internally and externally with clients as appropriate.
Provides quality data to Project Manager for the purpose of creating KPI metrics.
Builds rapport with clients and troubleshoots issues of concern with internal team in order to provide the highest quality services which meet the needs and requirements of our clients.
Updates and maintains accurate information for each client on project-related documentation repository (i.e., SharePoint).
Communicates internally within QA team to provide key updates on project status, timelines, and deliverables.
Formulates and prioritizes appropriate responses to client requests or concerns.
Trains Quality Associates on client specific processes to ensure records are complete, accurate and submitted by agreed deadline.
Supports, participates and follows up appropriately to internal, regulatory agency and client audit requests on a timely basis.
Identifies and supports continuous improvement opportunities working cross departmentally or cross functionally n order to enhance operations.
Other duties may be assigned
Minimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred.
Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required.
Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
Familiar with FDA, ISO, and other regulatory agency guidelines.
Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required.
Working knowledge and technical understanding of aseptic manufacture of biologics preferred.
Experience in both clinical and commercial manufacturing is preferred.
Experience participating health authority inspections and/or client audits preferred.
Experience in organizing teams for effective and timely completion of projects.