Overview
Quality Assurance Specialist Jobs in Durham, USA at ALOIS Solutions
Job Title: Quality Assurance Specialist
Location: Durham, NC 27709
Duration: 10+ Months (Possibility of Extension)
Job Summary
The QA Contractor, GMP Quality Assurance, reporting to the Manager, GMP Quality Assurance (or designee), will be responsible for assisting in the management of the organization’s Quality Management System (QMS) and supporting a strong Culture of Quality. This role ensures compliance with applicable GMP national, international, and state regulations. The position is based onsite with minimal domestic travel (less than 10%).
Job Responsibilities
- Manage day-to-day QA responsibilities in support of the Quality Management System (QMS).
- Provide timely support for Learning Management Systems, Change Control, Deviation Management Systems, and other QMS-related requests.
- Liaise with department record owners to ensure timely completion and resolution of records. Review and approve records as assigned.
- Deliver accurate weekly and quarterly QMS metrics and Key Performance Indicators (KPIs) to senior management.
- Collaborate cross-functionally to ensure tasks are completed within project timelines.
- Draft and review SOPs and controlled documents.
- Perform quality review and approval of QMS records related to Learning Management, Non-Conformance, CAPA, and KPI reporting.
- Continuously evaluate systems and procedures for improvements in efficiency and regulatory compliance.
- Participate in project meetings as a Quality Unit representative and provide technical support on quality and compliance issues.
- Perform customer-facing QA activities, including document archival and logbook management.
- Support continuous improvement initiatives and provide oversight of QMS activities.
- Assist in qualification and oversight of vendors, contract manufacturers, laboratories, and service providers.
- Support internal and regulatory audits/inspections.
- Communicate project status to stakeholders and elevate issues as needed.
- Perform additional duties as assigned.
Qualifications
- Bachelor’s degree in a scientific field with 4+ years of GMP Quality Assurance experience supporting a QMS, or 10+ years of relevant GMP QA experience.
- Minimum 3+ years of experience working with QMS platforms such as Track Wise, Veeva, ZenQMS, or similar systems.
- Strong knowledge of GMP guidelines and quality systems with the ability to apply regulatory standards.
- Experience authoring, reviewing, and interpreting SOPs.
- Ability to identify and resolve quality issues in a proactive and collaborative manner.
- Strong attention to detail with excellent organizational and multitasking skills.
- Effective communication and collaboration skills in cross-functional environments.
- Experience in analytical method validation and QC testing (biologics, cell culture, or related areas) is preferred.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
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Title: Quality Assurance Specialist
Company: ALOIS Solutions
Location: Durham, USA
Category:
