GMP Quality Assurance Analyst

Job Title:
Quality Assurance Specialist / QA Contractor, GMP Quality Assurance
Location:
Research Triangle Park, NC – 27709
Duration: 12 Months contract
Pay range: $30/hr - $40/hr on W2
Job Responsibilities:

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.

• 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 escalatem 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.).