Highlights
GxP documents are current, approved, and accessible and follow document lifecycle requirements supporting minimal manual documentation through digital implementations. Demonstrated ability to assemble and lead small high-performing teams, proactively remove barriers to success, and foster alignment through consensus-building.
Numbers & Facts
| Location | Wilson, NC |
| Industry | Staffing/Employment Agencies |
| Company Size | 100 to 499 employees |
| Year Founded | 1990 |
| Website | http://www.sunrisesys.com/ |
Description
Job Title: QA Validation Specialist
Location: Wilson ,NC
Duration:06 months on contract
Description:
The QA Validation Specialist is responsible to ensure that equipment, systems, and processes meet regulatory and internal quality standards through rigorous validation and qualification activities. This position focuses on the development, execution, and lifecycle management of validation protocols for equipment, utilities, and processes in a GMP-compliant pharmaceutical environment.
Validation Lifecycle Management
Location: Wilson ,NC
Duration:06 months on contract
Description:
The QA Validation Specialist is responsible to ensure that equipment, systems, and processes meet regulatory and internal quality standards through rigorous validation and qualification activities. This position focuses on the development, execution, and lifecycle management of validation protocols for equipment, utilities, and processes in a GMP-compliant pharmaceutical environment.
Validation Lifecycle Management
- Define and establish scope, objectives, and strategic approach for validation activities to ensure alignment with regulatory and quality standards.
- Support the development and review of validation protocols (IQ/OQ/PQ) for equipment, utilities, and manufacturing processes.
- Ensure validation activities align with FDA, EMA, and ICH regulatory requirements and internal quality systems.
- Maintain the validated state of systems through periodic reviews, requalification, and change control assessments.
Support for Engineering and Manufacturing
- Collaborate with Engineering and Validation teams to ensure equipment design, installation, and operation meet GMP and validation requirements.
- Participate in risk assessments (e.g., FMEA, HACCP) for new and modified systems to proactively identify and mitigate potential quality and compliance risks.
- support review of change controls, equipment specifications, and commissioning documentation.
- Promote consistent validation practices by providing coaching, hands-on support, and leading by example to reinforce quality standards and team alignment.
Compliance and Documentation
- Ensure validation documentation adheres to data integrity principles and regulatory expectations.
- Maintain accurate and complete validation records in accordance with internal SOPs and quality standards.
- Support internal and external audits by providing validation documentation and subject matter expertise.
Deviation and CAPA Support
- Investigate validation-related deviations and non-conformances.
- Support root cause analysis and implementation of corrective and preventive actions (CAPAs).
Cross-functional Collaboration
- Work closely with Quality Assurance, Quality Control, Regulatory Affairs, Engineering, and Manufacturing teams.
- Provide guidance on validation best practices and compliance requirements.
- GxP documents are current, approved, and accessible and follow document lifecycle requirements supporting minimal manual documentation through digital implementations.
- Support Management in the development, implementation, sustainability and improvements of the trainings systems and standards for the new production site.
- Maintain new hire orientation training materials supporting sustainability and continuous improvement opportunities to the training system to ensure best in class.
- Generate reports and support training opportunities for continuous improvement.
- Support assign, monitor, and communicate training requirements
- Identify and drive opportunities for continuous improvement in validation processes, with a focus on enhancing quality, reducing costs, and optimizing service delivery to stakeholders.
PROFESSIONAL QUALIFICATIONS
- Bachelor's degree in Life Sciences, Engineering, or related field.
- 3+ years of validation experience in pharmaceutical environment.
- Experience with risk-based validation approaches and quality systems.
- Proficiency in Microsoft Office Suite and validation software tools.
- Excellent analytical, documentation, and communication skills.
SKILLS & EXPERIENCE
- Collaborates with cross-functional teams and experience supporting validation projects.
- Knowledge regulatory guidelines (FDA, EMA, ICH Q7 Q10), GAMP 5, and data integrity principles.
- Strong analytical, documentation, and communication skills.
- Demonstrated ability to assemble and lead small high-performing teams, proactively remove barriers to success, and foster alignment through consensus-building.
- Experience with software and enterprise systems (e.g., VeevaVault, SAP, Client-X)
- Experience in validated computer systems and knowledge of CSA / Data Integrity requirements.
- Hands-on experience applying LEAN methodologies (e.g. Value Stream Mapping, Kaizen, Root Cause Analysis) to drive process efficiency and continuous improvement.
PERSONAL ATTRIBUTES
- Detail-oriented and proactive.
- Professional and composed during high-stakes inspections.
- Strong interpersonal skills for cross-functional collaboration.
- Adaptable to change and committed to continuous improvement.
About Company
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from:
- Business, management, and technical fields
- Information technology consulting and software solutions.
- Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
- Motivating technology staff and establishing partnerships with Fortune 500 companies
Sunrise Systems has a vast range of competence in:
- Design, development, and support of cloud-based solutions from simple to highly complexed
- Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
- Data processing and data migration
- Application re-engineering and platform migration
- Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.