QA Contractor, GMP Quality Assurance
TalentBurst, Inc.
Research Triangle Park, NC
Research Triangle Park, NC 27709
12 Months
Description:
The QA Contractor, GMP Quality Assurance, reporting to the Director, GMP Quality Assurance, or designee. This role will assure corporate compliance with applicable GMP national, international, and state regulations. This position will be based at our headquarters facility in RTP, NC with domestic travel (less than 10% of the time) expected.
Job Responsibilities
Manage assigned day-to-day QA responsibilities in support of the company's Product Quality systems.
Provide timely support for Third Party Deviations, Third Party Change Controls, and Vendor Management (qualification and oversight of vendors, contract manufacturers, contract laboratories, and service providers) activities. Liaison with applicable department record owners to ensure their complete and timely resolution.
Collaborate successfully with the other departments to ensure that direct and supportive tasks are completed within project timelines. Providing deliverables and resolving issues, as needed.
Communicate project status to stakeholders and escalate issues in a timely manner.
Perform daily customer-facing activities, as assigned by area management.
Perform and support other duties as assigned by area management.
About you
Bachelor's degree in a scientific field and 2 years of experience in GMP based Quality Assurance, particularly in support/oversight of a company QMS, or 5 years of GMP based Quality Assurance experience using a company QMS.
Experience working within a pharmaceutical/biotech Quality Management system, such as Trackwise, ZenQMS, Veeva, is a requirement.
Strong 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 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.
Strong service-oriented mindset with 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, etc.).
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About the Company
TalentBurst, Inc.
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!