What are the responsibilities and job description for the QA Contractor, GMP Quality Assurance position at TalentBurst, Inc.?
Title : QA Contractor, GMP Quality Assurance
Location : Research Triangle Park, NC
Duration : 9 Months of contract
The QA Contractor, GMP Quality Assurance, reporting to the Manager, GMP Quality Assurance, or designee, will be responsible for assisting in the management of Quality Management System (QMS) and will strongly support Culture of Quality. This role will assure corporate compliance with applicable GMP national, international, and state regulations. This position will be based at our headquarters facility in RTP, NC with domestic travel (less than 10% of the time) expected.
Job Responsibilities
- Manage assigned day-to-day QA responsibilities in support of the company's Quality Management Systems (QMS).
- Provide timely support of Learning Management System, Change Control, Deviation Management Systems, or other QMS based customer requests. Liaison with applicable department record owners to ensure their complete and timely resolution. Review and Approve said record types as assigned.
- Provide accurate and timely weekly and quarterly QMS metric and Key Performance Indicator updates to QA and CMC senior management.
- Collaborate successfully with the other departments to ensure that direct and supportive tasks are completed within project timelines. Providing deliverables and resolving issues; Draft SOPs / controlled documents as well as perform quality unit review and approval of Quality Management Systems requests / records related to Learning Management, Non-Conformance Management, CAPA management, and metric / KPI reporting.
- Continually evaluate systems and procedures for improvement for efficiency and compliance to applicable regulatory requirements and standards.
- Participate in project meetings as a Quality Unit representative and support colleagues by acting as a technical resource for quality and compliance related issues.
- Perform daily customer-facing activities, as assigned by area management. Maintain health of customer-facing activities such as document archival activities and notebook / logbook assignment and management.
- Identify and collaborate with colleagues to implement continuous improvement initiatives; provide Quality Unit oversight of QMS based activities.
- Assist in the qualification and oversight of vendors, contract manufacturers, contract laboratories, and service providers.
- Support regulatory (FDA, EMA) and internal audits / inspections per procedures and applicable regulatory requirements.
- Communicate project status to stakeholders and escalate issues in a timely manner.
- Perform and support other duties as assigned by area management.
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