GMP Quality Assurance Specialist

2 weeks ago


Durham, North Carolina, United States TalentBurst Full time
Quality Assurance Contractor Job Description

**Job Summary**

We are seeking a highly skilled Quality Assurance Contractor to join our team at TalentBurst. As a Quality Assurance Contractor, you will be responsible for assisting in the management of Quality Management System (QMS) and supporting the Culture of Quality.

**Key Responsibilities**

- Assist in the management of Quality Management System (QMS) and support the Culture of Quality
- Ensure corporate compliance with applicable GMP national, international, and state regulations
- Work alongside department customers on development, implementation, and integration of Equipment and Computer Systems Validation plans for site-wide equipment onboarding
- Provide timely quality support and thorough reviews and approvals of various records, including Change Controls, SOPs, analytical method, equipment, and computer system qualification and validation plans, protocols, and summary reports, batch records, QC data, non-conformities, and Corrective Action/Preventive Action (CAPAs)
- Ensure QA-related activities are performed within the associated project timeline
- Effectively escalate concerns to area and project management
- Report on applicable key metrics to drive continuous improvement in compliance

**Requirements**

- Bachelor's degree in a scientific field
- 5+ years of experience in pharmaceutical, biotech, or biologics GMP regulated manufacturing environment with 3+ years in Quality and/or Manufacturing
- Solid understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards
- Ability to author, review, and interpret Standard Operating Procedures (SOPs)
- Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner
- Strong attention to detail, highly organized, and the ability to multitask in a fast-paced, highly interactive environment
- Ability to manage workload effectively in order to meet project timelines
- Excellent verbal and written communication skills, and the ability to effectively collaborate with peers, including scientific/technical colleagues
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)

**About Us**

TalentBurst is a leading provider of talent solutions, and we are committed to delivering exceptional results for our clients. We are seeking a highly skilled Quality Assurance Contractor to join our team and contribute to our mission of excellence.

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