Quality Assurance Analyst

Job Title: Quality Assurance Analyst

Location: Durham, NC

Job Summary:

• The Quality Assurance Analyst, reporting to the Manager, GMP Quality Assurance, or designee, will be responsible for assisting in the management of the company's Quality Management System (QMS) and will strongly support the company's Culture of Quality.
• This role will ensure corporate compliance with applicable GMP national, international, and state regulations.

Job Responsibilities

• Manage assigned day-to-day QA responsibilities in support of the company’s Quality Management Systems (QMS).
• Provide timely support of Learning Management System, Change Control, Deviation Management Systems, or other QMS-based customer requests.
• Provide accurate and timely weekly and quarterly QMS metric and Key Performance Indicator updates to QA and CMC senior management.
• Collaborate successfully with the other departments to ensure that direct and supportive tasks are completed within project timelines.
• Participate in project meetings as a Quality Unit representative and support colleagues by acting as a technical resource for quality and compliance-related issues.
• Identify and collaborate with colleagues to implement continuous improvement initiatives; provide Quality Unit oversight of QMS-based activities.
• Support regulatory (FDA, EMA) and internal audits/inspections per the company's procedures and applicable regulatory requirements.
• Communicate project status to stakeholders and escalate issues in a timely manner.
• Perform and support other duties as assigned by area management.

About you:

• Bachelor’s degree in a scientific field and 4 years of experience in GMP-based Quality Assurance, particularly in support/oversight of a company QMS, or 10 years of GMP-based Quality Assurance experience using a company QMS.
• 3 years of 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 author, review, and interpret Standard Operating Procedures (SOPs).
• Experience in analytical method validation and QC testing, especially in the fields of mammalian cell culture and Gene Therapy/Biologics based potency testing, is preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).