GMP, QUALITY ASSURANCE ASSOCIATE II

Duke Careers•Durham, NC

2d•$86,714 - $140,129•Onsite

About The Position

The Office of Regulatory Affairs & Quality (ORAQ) is looking for a GMP, Quality Assurance Associate II, to join our team. In this role, you will help ensure that the products, materials, and processes used in Duke’s GMP programs meet the highest standards of quality and compliance. You will play a key part in supporting the Marcus Center for Cellular Cures (MC3) GMP Facility—an innovative environment where your work directly impacts clinical research and patient-focused manufacturing. You will work with a wide range of partners across manufacturing, engineering, validation, and quality functions. Your days will include work on supporting and evolving quality systems, including supporting investigations, building tools to analyze and assess quality metrics, supporting robust supplier qualifications systems, inspection readiness planning and training, and guiding teams on GMP expectations. You’ll also help shape continuous improvement efforts and support inspections, giving you a front-row seat to the full lifecycle of GMP operations.

Requirements

Bachelor’s degree in life sciences or a related field.
5 years of experience in a GXMP or similar regulated environment.
Experience training users in implementing Quality Systems.
Experience preparing for external audits and/or site visits.
Experience reviewing raw materials, supplies, and manufactured products for acceptability.
Experience with validation and/or technical quality engineering support of manufacturing operations (required).
Proficient knowledge of GLP, GMP, and/or GTP.
Strong leadership, organizational, and time-management skills.
Ability to train staff effectively.
High attention to detail in document review.
Strong interpersonal, verbal, and written communication skills.
Ability to work independently or collaboratively in a fast-paced environment.
Adaptability to shift priorities.
Problem-solving skills and a sense of urgency in completing tasks.

Nice To Haves

Prior laboratory experience preferred.
Experience serving as final QA signature for release of raw materials or finished products.
Experience representing QA in cross-functional settings and reporting back to the department.

Responsibilities

Review and support change control for development, modification, and manufacturing process changes.
Represent QA in project meetings and provide quality guidance.
Write, revise, and review SOPs to support compliant operations.
Lead or support continuous improvement initiatives across GMP programs.
Track and trend quality metrics to identify areas of concern.
Assist with inspections and manage quality-related matters during audits.
Review and guide deviations and investigations, collaborating with end users to resolve issues.
Train staff on GMP principles, investigations, and root cause analysis.
Review product records for release of clinical trial materials and components, when required.
Participate in multiple programs across various development phases.
Conduct environmental monitoring and assist with data analysis, when required.
Conduct audits under the supervision of the Lead Auditor and generate audit reports.