GMP, Quality Control Associate II

Duke Careers•Durham, NC

4d•$86,714 - $140,129•Onsite

About The Position

The Office of Regulatory Affairs & Quality (ORAQ) is seeking a GMP, Quality Control Associate II to join their team. This role will support the development, qualification, and execution of analytical methods for the release of cellular therapy products used in clinical trials and commercial operations. The Associate will perform specialized GMP testing, environmental monitoring, and quality control activities with minimal oversight to ensure product and facility compliance with regulatory requirements. This position is an integral part of a collaborative Quality Control team, working closely with Manufacturing, Product Development, and external partners to ensure the production of high-quality clinical and commercial cellular therapy products. The role also involves serving as a technical resource to manufacturing operations and junior staff, contributing expertise to investigations, process improvements, and regulatory readiness activities.

Requirements

Bachelor’s degree
5 years of experience in a GxMP or similarly regulated environment
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
Proficient working knowledge of GLP, GMP, and/or GTP
Strong organizational and time-management 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 problem-solving 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

Nice To Haves

Experience serving as final signature authority for QC release of test results, raw materials, and finished products
Experience representing the Quality Control department in cross-functional meetings and reporting outcomes to QC leadership
Experience leading laboratory investigations, root cause analysis, and CAPA development
A Master’s or PhD may substitute for required experience

Responsibilities

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, non-conformances, 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 cross-functional 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