Quality Control Associate I, GMP

Be You.

The Cellular Therapy and GMP Manufacturing team is seeking a GMP Quality Control Associate I to help advance the development and delivery of innovative cellular therapies for clinical and commercial applications. In this role, you will support analytical development, product release testing, environmental monitoring, and quality systems activities within a GMP-regulated environment. Your work will directly contribute to ensuring that cellular therapy products meet the highest standards of quality, safety, and regulatory compliance while supporting groundbreaking therapies for patients.

This is an excellent opportunity for a quality-focused laboratory professional who enjoys working in a fast-paced, collaborative environment and wants to contribute to the advancement of novel cell and gene therapies.

Minimum Requirements: 

• Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific field.
• Two years of experience in a laboratory, manufacturing, quality, or other regulated environment.

Essential Tasks

• Perform pharmaceutical development and successful GMP release including Analytical development, assisting the QC Manager and Product Development team in development of specific release and characterization methods
• Aid in qualifying methods for product release and complete comprehensive characterization of clinical lots.
• Complete GMP testing in line with ICH and regulatory guidance.
• Lead qualification testing of cellular therapy products including tech transfer and associated testing under GMP conditions.
• Execute and document development and GMP activities in compliance with regulatory requirements.
• Collaborate closely with other development teams to provide support for development activities and will work diligently with other development functions to understand how the production process changes impact product quality.
• Compile data and perform analysis and interpretation and draw conclusions regarding progress and results of work, utilize the data in appropriate decision making; summarize data, present results, and propose next steps to advance development.
• Write and reviews development reports; writes protocols for use in GMP facility and SOPs for GMP production and presents data to project teams and larger settings.
• Write and review QC deviations, non-conformances, CAPAs, out of specifications, complaints, and all associated required reporting.
• Ship and prepare samples for outside vendors for quality control testing. Engage external vendors for coordination of quality control testing.
• Operate and maintain equipment utilized in characterization and qualification testing.
• Perform routine environmental monitoring of the GMP Facility to ensure facility remains in state of microbial control.
• Execute activities in a cleanroom environment while following associate GMP and regulatory guidelines.
• Ability to independently support project teams on event/deviation composition, including associated investigations, assessment for impact/risk, root cause analysis, and CAPA requirements/documentation
• Event Management with assistance -In conjunction with the QA Manager/Director, develop, write, and review analytical, equipment and process validations.

Skills:

Required:

• Knowledge and hands on classwork with analytical methods and/or product formulation.
• Hands on experience with analytical methods (GMP product release testing and/or Product characterization testing), molecular or pharmaceutical product formulation (buffer & excipient screening, thermal stability evaluation, biophysical methods) is preferred. GMP experience is a plus
• Must have the ability to work independently with guidance from senior scientists/management.
• Demonstrated ability in solving moderately complex analytical problems with guidance from senior management.
• Strong oral and written communication skills
• Must be able to manage multiple and rapidly changing priorities and have ability to quickly learn new skills and concepts.

Preferred:

• Knowledge and hands on classwork with analytical methods and/or product formulation.
• Experience working in or with a Quality Department
• Experience with Environmental monitoring
• Experience in a GMP environment
• Experience in preparing for external audits or site visits
• A Master's or PhD can substitute for experience

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

Be Bold.                                   

As a GMP Quality Control Associate I, you will:

• Perform analytical development, product characterization, and GMP release testing activities to support cellular therapy programs.
• Execute and document testing, method qualification, and technology transfer activities in compliance with GMP and regulatory requirements.
• Monitor the GMP facility through routine environmental monitoring activities to ensure continued microbial control and regulatory compliance.
• Investigate and support quality events, including deviations, CAPAs, non-conformances, out-of-specification results, and related documentation.
• Collaborate with manufacturing, process development, quality assurance, and external testing partners to ensure successful product development and release.

Choose Duke.

Join a team dedicated to developing next-generation cellular therapies that have the potential to transform patient care. You will work alongside talented scientists, manufacturing specialists, and quality professionals in a collaborative environment where innovation, quality, and patient safety are at the center of everything we do.

At Duke, you'll have the opportunity to expand your expertise in GMP manufacturing, quality control, and advanced therapeutic development while contributing to groundbreaking research and clinical advancements that make a meaningful impact.