Highlights
The role serves as a Subject Matter Expert (SME) for sampling and inspection activities involving chemical components, bulk products, containers and closures, labeling, and packaging materials while ensuring compliance with GMP, safety, and quality requirements. The Specialist Technical Assurance provides testing, sampling, inspection, and technical support for the Quality Assurance department within the logistics area.
Numbers & Facts
| Location | Fort Washington, PA |
| Industry | Staffing/Employment Agencies |
| Company Size | 100 to 499 employees |
| Year Founded | 1990 |
| Website | http://www.sunrisesys.com/ |
Description
Job Title: Specialist Technical Assurance
Duration: 15+ months contract on w2
Location: Fort Washington, PA 19034
Position Summary
The Specialist Technical Assurance provides testing, sampling, inspection, and technical support for the Quality Assurance department within the logistics area. The role serves as a Subject Matter Expert (SME) for sampling and inspection activities involving chemical components, bulk products, containers and closures, labeling, and packaging materials while ensuring compliance with GMP, safety, and quality requirements.
Key Responsibilities
Sharath Babu: sharath.b@sunrisesys.com | (732) 395-4575 | URL: www.sunrisesys.com
Duration: 15+ months contract on w2
Location: Fort Washington, PA 19034
Position Summary
The Specialist Technical Assurance provides testing, sampling, inspection, and technical support for the Quality Assurance department within the logistics area. The role serves as a Subject Matter Expert (SME) for sampling and inspection activities involving chemical components, bulk products, containers and closures, labeling, and packaging materials while ensuring compliance with GMP, safety, and quality requirements.
Key Responsibilities
- Perform sampling and inspection of:
- Chemical components
- Bulk products
- Containers and closures
- Labeling and packaging materials
- Support packaging material review and disposition activities.
- Prepare, label, and deliver samples to the laboratory for testing.
- Train and mentor sampling and inspection personnel.
- Support audits, regulatory inspections, and audit observation resolution.
- Assist with SOP revisions, process improvements, and continuous improvement initiatives.
- Track packaging component inspection and annual testing requirements.
- Maintain accurate GMP documentation and records.
- Participate in investigations and quality-related activities.
- Support safety, environmental, and compliance programs.
- High School Diploma or equivalent required.
- Minimum 4 years of experience in a pharmaceutical and/or OTC manufacturing environment.
- Warehousing and inventory control system experience required.
- Sampling and inspection experience in a pharmaceutical and/or OTC environment preferred.
- Strong GMP knowledge and compliance focus.
- Ability to work effectively with all levels of the organization.
- Strong interpersonal and teamwork skills.
- Basic computer proficiency.
- SAP
- LIMS
- Microsoft Excel
- MS Office applications
- ERP systems
- Electronic batch records and automated quality systems experience preferred
- Pharmaceutical/OTC sampling and inspection.
- Quality Assurance or Quality Control support.
- Packaging component inspection.
- Continuous improvement, Lean, and process excellence initiatives.
Sharath Babu: sharath.b@sunrisesys.com | (732) 395-4575 | URL: www.sunrisesys.com
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.