USA-Quality Manager III (Engineering) - Contract
TalentBurst, Inc.
- Swiftwater, PA
- 8 days ago
- $86.43 Per Hour
Highlights
Proven ability to collaborate effectively with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs. Qualifications & Experience: Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required; Master's degree preferred.
Numbers & Facts
| Location | Swiftwater, PA |
| Industry | Staffing/Employment Agencies |
| Salary | $86.43 Per Hour |
| Company Size | 5,000 to 9,999 employees |
| Year Founded | 2002 |
| Website | http://www.talentburst.com/ |
Description
Job Title: Quality Validation Engineer / Validation Specialist
Location: Swiftwater, PA
Duration: 12 Months
Experience: 6-9 Years
Qualifications & Experience:
Key Competencies:
Location: Swiftwater, PA
Duration: 12 Months
Experience: 6-9 Years
Qualifications & Experience:
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required; Master's degree preferred.
- 6-9 years of experience in the pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments.
- Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.
- Demonstrated experience leading and managing Corrective and Preventive Action (CAPA) investigations and activities.
- Comprehensive knowledge of Quality System Regulations (QSR), GxP requirements, and industry best practices.
- Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
- Preferred experience in high-speed aseptic filling operations and sterile manufacturing environments.
- Proven ability to collaborate effectively with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.
- Strong analytical and problem-solving skills with exceptional attention to detail.
- Ability to manage multiple projects simultaneously while meeting aggressive timelines and strict deadlines.
- Excellent verbal and written communication skills, with the ability to present complex information clearly to diverse stakeholders.
- Self-motivated, organized, and capable of working independently in a fast-paced, regulated environment.
Key Competencies:
- Quality Validation & Compliance
- CAPA Management
- Regulatory Knowledge (FDA, GMP, GxP, QSR)
- Risk Assessment & Root Cause Analysis
- Cross-Functional Collaboration
- Project Management
- Technical Documentation & Reporting
- Continuous Improvement & Quality Excellence
About Company
For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.
Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!