QA Contractor, GMP Quality Assurance

• 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.

• 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.).

akarsh.yathiraj@leadstackinc.com