GMP, Quality Control Associate II

Be You.

The Office of Regulatory Affairs & Quality (ORAQ) is seeking a GMP, Quality Control Associate II to join our team. In this role, you will support the development, qualification, and execution of analytical methods required for the release of cellular therapy products used in clinical trials and commercial operations. With minimal oversight and often independently, you will perform specialized GMP testing, environmental monitoring, and quality control activities to ensure products and facilities remain compliant with applicable regulatory requirements.

As an integral member of a collaborative Quality Control team, you will work closely with Manufacturing, Product Development, and external partners to ensure the production of highquality clinical and commercial cellular therapy products. You will also serve as a technical resource to manufacturing operations and junior staff, contributing your expertise to investigations, process improvements, and regulatory readiness activities.

Minimum Requirements:

• Bachelor's degree
• 5 years of experience in a GxMP or similarly regulated environment

• (A Master's or PhD may substitute for required experience)

• Prior laboratory experience in product testing
• Experience training Quality personnel
• Experience preparing for and supporting external audits and/or site visits
• Experience reviewing raw materials, analytical methods, test results, supplies, and manufactured products for acceptability

Preferred Qualifications:

• Experience serving as final signature authority for QC release of test results, raw materials, and finished products
• Experience representing the Quality Control department in crossfunctional meetings and reporting outcomes to QC leadership
• Experience leading laboratory investigations, root cause analysis, and CAPA development

Other Requirements:

• Proficient working knowledge of GLP, GMP, and/or GTP
• Strong organizational and timemanagement skills with the ability to manage multiple priorities
• Demonstrated leadership abilities and experience mentoring or training junior staff
• Strong attention to detail, particularly in documentation and data review
• Excellent verbal, written, and interpersonal communication skills
• Strong problemsolving skills and adaptability to changing priorities
• Ability to work independently and collaboratively in a team environment
• Ability to work effectively in a GMP cleanroom environment

This position is Onsite. The work is performed on-site or at a designated assignment location.

Be Bold.

With minimal oversight and/or independently, you will:

• Perform pharmaceutical development and GMP release testing, including analytical method development in collaboration with the QC Manager and Product Development team
• Qualify analytical methods for product release and perform comprehensive characterization of clinical and commercial lots
• Execute GMP testing in alignment with ICH guidelines and regulatory requirements
• Lead qualification testing and technical transfer activities for cellular therapy products under GMP conditions
• Document and execute development and GMP activities in full compliance with regulatory and quality standards
• Collaborate with development and manufacturing teams to assess how process changes impact product quality
• Compile, analyze, interpret, and summarize data; present results and recommend next steps to advance development programs
• Author and review development reports, protocols, SOPs, and GMP documentation; present data to project teams and broader audiences
• Write, coordinate, and review deviations, nonconformances, OOS events, CAPAs, complaints, and required reports
• Prepare and ship samples to external vendors and coordinate outsourced quality control testing
• Operate, maintain, and qualify equipment used in characterization and qualification testing
• Perform routine environmental monitoring to ensure the GMP facility remains in a state of microbial control
• Serve as a key QC resource in the cleanroom and mentor junior staff in GMP best practices
• Provide Quality Control input on deviations and investigations, including risk assessments, root cause analysis, and CAPA documentation
• Represent the Quality Control department in project meetings and crossfunctional discussions
• Track and trend Quality Control metrics and proactively identify areas of concern
• Support multiple programs at various stages of development requiring differing levels of QC involvement
• In collaboration with the QC Associate Director, develop, write, and review analytical, equipment, and process validation documentation

Choose Duke.

At Duke University, you'll be part of a missiondriven organization dedicated to advancing innovative research and delivering lifechanging therapies. ORAQ plays a critical role in ensuring compliance, product quality, and patient safety across GMP programs supporting novel cellular therapies. This role offers opportunities for professional growth, leadership development, and meaningful collaboration in a highly regulated and impactful environment.