Durham, North Carolina, United States · On-site
$87k–$140k/yr
School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusi…
Skills: GMP Compliance, Quality Assurance, Quality Systems Implementation, External Audit Preparation, Validation
Durham, North Carolina, United States · Remote Solely
$68k–$116k/yr
School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusi…
Skills: Grants Management, Contract Management, Pre-award Administration, Post-award Administration, Budget Reconciliation
Holly Springs, North Carolina, United States · On-site
Overview The Warehouse Associate 2 position is responsible for storage, handling, and distribution of materials and products. This role supports Warehouse operations in receiving, shipping, and/or logistics throughout FD…
Skills: SAP ERP, Inventory Management, Cycle Counting, GMP, SOP Compliance
Durham, North Carolina, United States · On-site
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advanc…
Skills: Sterile compounding, Intravenous admixtures, Pharmacy operations, Medication dispensing, Medical terminology
AtsenaDurham, North Carolina, United States · Remote OK
The Senior Manager, Clinical Quality Operations will be responsible for Quality project management of pre-clinical and clinical programs by providing GXP support to Atsena Therapeutics’ Clinical, CMC, and Nonclinical tea…
Skills: Quality Project Management, GXP Support, Vendor Oversight, QMS Implementation, Veeva Vault QualityDocs
Charlotte, North Carolina, United States · Hybrid
The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. To date, over 45 therapies conducted at START locations have obtained FDA/EMA…
Skills: Clinical Research Operations, Nursing Leadership, Oncology Research, Patient Care, Protocol Feasibility
Cary, North Carolina, United States · Hybrid
$100k–$153k/yr
Description This position will offer you the opportunity to work in a project team environment with other engineers and designers involved in the design, modification, and analysis of new and existing nuclear power plant…
Skills: Electrical System Design, Nuclear Power Plant Engineering, Power Studies, Short Circuit Analysis, Cable Ampacity
Charlotte, North Carolina, United States · Hybrid
$85k–$129k/yr
Description This position will offer you the opportunity to work in a project team environment with other engineers and designers involved in the design, modification, and analysis of new and existing nuclear power plant…
Skills: Electrical System Design, Power Plant Engineering, AC/DC Power Studies, Short Circuit Analysis, Cable Ampacity
Wake Forest, North Carolina, United States · On-site
Our Wake Forest Pet Care Center is Hiring!Help Us Redefine the Future of Pet Care At Petfolk, we’re on a mission to transform pet care by building a compassionate, innovative team right here in Wake Forest. We improve th…
Skills: Venipuncture, Surgical Assistance, Dental Procedures, Patient Exams, Fear Free Handling
Wilson, North Carolina, United States · Remote OK
Description ABEC’s Headquarters in Bethlehem, PA serves a global market. To support our growth, ABEC is seeking a remote Regional Sales Manager who will be responsible for top-line sales growth in the Service Business Un…
Skills: Consultative Selling, Strategic Negotiation, Account Management, Prospecting, CRM Software
Durham, North Carolina, United States · On-site
Division Overview Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India.…
Skills: Analytical Chemistry, Method Development, Method Validation, Gas Chromatography, HPLC
Newton, North Carolina, United States · On-site
Title: Quality Assurance Technician Department: Quality Assurance Reports To: Refer to location organizational chart Flip your Career At Mennel, we believe in doing right and bringing our best to our people who are helpi…
Skills: Quality Assurance, Food Safety, Sample Analysis, Calibration, Troubleshooting
Cary, North Carolina, United States · On-site
Overview The Exercise Specialist provides exercise programming, prescription, and exercise therapy for the cardiac rehab program and assists as needed in the provision of other department functions for individuals with m…
Skills: Exercise Programming, Exercise Prescription, Exercise Therapy, Clinical Expertise, Exercise Science
High Point, North Carolina, United States · On-site
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycl…
Skills: Windows 10/11, Microsoft 365, Workstation Imaging, ITSM Ticketing, TCP/IP Networking
Clayton, North Carolina, United States · On-site
Company Description Plantation Park Animal Hospital is a full-service hospital with innovative and progressive treatment options, including digital X-ray, low level therapy laser, full in-house CBC, and chemistry, chemot…
Skills: Pet Restraint, Triage, Lab Sample Collection, Diagnostic Imaging, Nursing Care
Winterville, North Carolina, United States · On-site
Overview Care for animals. Support your team. Make a difference every single shift. At Winterville Animal Care , we know it takes a village to care for pets and Veterinary Assistants are the glue that holds it all togeth…
Skills: Animal Care, Patient Restraint, Medical Record Keeping, Surgery Preparation, Medication Administration
Charlotte, North Carolina, United States · On-site
Location: On site at location listed in job posting SUMMARY At First Horizon, the Senior Model Risk Consultant, under the supervision of the Director of Model Risk Management, will be responsible for executing best-in-cl…
Skills: Model Validation, Econometric Modeling, Time Series Regression, Python, R
Whitsett, North Carolina, United States · On-site
At Cross Company, we don’t just show up for work—we show up for a company we actually own. As a 100% employee-owned industrial technology leader, we provide specialized expertise in automation, hydraulics, pr…
Skills: Precision Measurement, Calibration, Gage Management Software, Microsoft Office, Instrumentation
Raleigh, North Carolina, United States · On-site
If you are an experienced engineer who enjoys solving ambiguous problems of national importance and wants to shape how complex systems are built and integrated, this role is for you. You will work in a stable environment…
Skills: Java, Python, C++, TypeScript, REST API
Randolph County, North Carolina, United States · Remote Solely
$155k–$175k/yr
At Emerald Clinical Trials, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise…
Skills: Clinical Project Management, Nephrology, Budget Management, ICH-GCP, Vendor Management
Durham, North Carolina, United States • On-site
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Ensure products and processes in Duke's GMP programs meet quality and compliance standards, specifically supporting the Marcus Center for Cellular Cures. Responsibilities include managing change controls, writing SOPs, leading continuous improvement initiatives, and guiding investigations and audits.
Requires a Bachelor's degree in life sciences and 5 years of experience in a GXMP or similar regulated environment. Must have experience in validation, technical quality engineering, and training users on Quality Systems.
Be You.
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.
· Bachelor’s degree required
· 5 years of experience in a GXMP or similar regulated environment.
· Experience training users in implementing Quality Systems.
· Prior laboratory experience preferred.
· Experience preparing for external audits and/or site visits.
· Experience reviewing raw materials, supplies, and manufactured products for acceptability.
· Master’s or PhD may substitute for experience
· Or any equivalent combination of relevant education and/or experience.
· Bachelor’s degree in life sciences or a related field.
· 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.
· Experience with validation and/or technical quality engineering support of manufacturing operations (required).
· Master’s or PhD may substitute for experience except for validation/technical quality engineering requirements.
· 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.
This position is Onsite. The work is performed on-site or at a designated assignment location.
Be Bold.
You will:
· 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.
Choose Duke.
At Duke, you’ll join a community committed to advancing science, improving health, and supporting groundbreaking clinical research. The Office of Regulatory Affairs & Quality plays a vital role in ensuring that Duke’s GMP programs operate with excellence, integrity, and compliance. You’ll be part of a collaborative, mission-driven environment where your expertise directly contributes to the success of innovative cellular and gene therapy programs.
Working within the Marcus Center for Cellular Cures (MC3), you’ll support cutting-edge manufacturing that impacts real patients and drives the future of regenerative medicine. Duke offers a culture of learning, growth, and teamwork—where your contributions are valued and your professional development is supported.
Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $86,714.00 to USD $140,129.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.
Your total compensation goesbeyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/
Equal Opportunity Employer: Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender,gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.
Duke aspires to create a community built oncollaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Duke Health Technology Solutions is a robust, specialized division of Duke University Health System dedicated to the development and management of enterprise IT systems. A 2018 Davies Award Recipient, Duke Health is nationally recognized for IT and information management as the first healthcare system to be awarded top honors by the Healthcare Information and Management Systems Society (HIMSS) for inpatient, ambulatory and analytics health information technology capabilities. As a ‘Most Wired’ health system, our employees are among the top-skilled IT experts in the Triangle and work with leading scholars and researchers across Duke University to develop innovative technologies that support our mission of delivering tomorrow's healthcare today.
Offices: 2424 Erwin Road, Durham, NC 27715, US
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