Durham, North Carolina, United States · On-site
$68k–$103k/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, Technical Writing, CAPA, Deviation Management
Durham, North Carolina, United States · On-site
Your Impact at Lowe's As a Lowe's Merchandising Services Associate, you are a key connection point between Merchandising and Store Operations, allowing us to deliver a great shopping experience in every Lowe's store. If …
Skills: Merchandising, Planogram Reading, Display Setup, Inventory Management, Pricing Accuracy
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: Budget Projections, Statistical Reporting, Trend Analysis, Interviewing Skills, Personnel Practices
Durham, North Carolina, United States · On-site
Your Impact at Lowe's As a Lowe's cashier, you'll ensure every customer exits Lowe's on a high note. Your work helps our stores positively serve our customers and communities by providing a quick, friendly checkout exper…
Skills: Cash Handling, Customer Service, Point of Sale (POS), Basic Arithmetic, Computer Literacy
Durham, North Carolina, United States · On-site
Your Impact at Lowe’s As a Receiver/Stocker, you help keep the store clean, safe, and ready for customers by accurately receiving freight, stocking shelves, and organizing merchandise and top stock. You’ll unload deliver…
Skills: Freight Receiving, Stocking, Inventory Handling, Forklift Operation, Pallet Jack Operation
Durham, North Carolina, United States · On-site
Your Impact at Lowe's As a Customer Service Associate, you combine top-notch customer service skills with genuine care for people to help customers feel comfortable while shopping at Lowe's. This is an excellent role for…
Skills: Customer Service, Retail Sales, Inventory Management, Basic Arithmetic, Computer Literacy
Durham, North Carolina, United States · On-site
Your Impact at Lowe’s As a Receiver/Stocker, you help keep the store clean, safe, and ready for customers by accurately receiving freight, stocking shelves, and organizing merchandise and top stock. You’ll unload deliver…
Skills: Freight Receiving, Stocking, Inventory Handling, Forklift Operation, Pallet Jack Operation
Durham, North Carolina, United States · On-site
Your Impact at Lowe’s As a Receiver/Stocker, you help keep the store clean, safe, and ready for customers by accurately receiving freight, stocking shelves, and organizing merchandise and top stock. You’ll unload deliver…
Skills: Freight Receiving, Stocking, Inventory Handling, Forklift Operation, Pallet Jack Operation
Durham, North Carolina, United States · On-site
Your Impact at Lowe's As a Lowe's Merchandising Services Associate, you are a key connection point between Merchandising and Store Operations, allowing us to deliver a great shopping experience in every Lowe's store. If …
Skills: Merchandising, Planogram Reading, Display Setup, Inventory Management, Pricing Accuracy
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: Patient Assessment, Diagnosis, Treatment Planning, Pediatric Cardiac Care, Postoperative Management
Durham, North Carolina, United States · On-site
$96k–$151k/yr
Job Description This requisition is for both day shift and night shift positions. This position is for a manufacturing leadership role as Operations Manager supporting the commercial-scale manufacture of vaccines and the…
Skills: People Leadership, Aseptic Manufacturing, cGMP Compliance, Process Improvements, Production Scheduling
Durham, North Carolina, United States · On-site
$106k–$167k/yr
Job Description This position is for a manufacturing leadership role as Maintenance Manager supporting the commercial-scale manufacture of vaccines and therapeutics at the Durham, NC site. The individual in this role mus…
Skills: Computerized Maintenance Management Systems (CMMS), Data Analysis Management, Electrical Maintenance, Equipment Modifications, Equipment Reliability Improvement
Durham, North Carolina, United States · Hybrid
About Us ACA Group is the leading governance, risk, and compliance (GRC) advisor in financial services. What sets us apart is the breadth and depth of our integrated platform — we offer the most comprehensive compliance …
Skills: Cloud-native Software Design, Full-stack Development, UX Design, Back-end Services, Infrastructure
Durham, North Carolina, United States · On-site
Labcorp is a leader in diagnostics, drug development and healthcare innovation. Across every role, we harness data and AI to work smarter, move faster and create breakthrough solutions that improve health outcomes for pe…
Skills: Information Architecture, Data Modeling, Star Schema, Dimensional Modeling, Relational Database Design
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: Clinical Leadership, Staff Supervision, Budget Monitoring, Patient Flow Management, Performance Appraisals
Durham, North Carolina, United States · On-site
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: Mathematical Statistics, Generative AI, Transformers, Agentic AI, Deep Learning
Durham, North Carolina, United States · On-site
$61k–$98k/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: Flow Cytometry, Cell Sorting, Panel Design, Sample Processing, Data Analysis
Durham, North Carolina, United States · On-site
Your Impact at Lowe's As a Lowe's cashier, you'll ensure every customer exits Lowe's on a high note. Your work helps our stores positively serve our customers and communities by providing a quick, friendly checkout exper…
Skills: Cash Handling, Customer Service, Point of Sale (POS), Basic Arithmetic, Computer Literacy
Durham, North Carolina, United States · On-site
Your Impact at Lowe's As a Customer Service Associate, you combine top-notch customer service skills with genuine care for people to help customers feel comfortable while shopping at Lowe's. This is an excellent role for…
Skills: Customer Service, Retail Sales, Inventory Management, Basic Arithmetic, Computer Literacy
Durham, North Carolina, United States · On-site
Service Center Durham - Downtown JOB SUMMARY Caliber Collision has an immediate job opening for an Auto Painter Helper to efficiently prepare vehicles for painting in cooperation with the Auto Painter to ensure efficient…
Skills: Sanding, Buffing, Paint Booth Maintenance, Vehicle Repair, Physical Stamina
Durham, North Carolina, United States • On-site
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Ensure the GMP manufacturing laboratory complies with FDA regulations and FACT accreditation standards by developing SOPs and managing batch records. Lead the investigation and closure of deviations, CAPAs, and change controls related to equipment and facilities.
Requires a bachelor's degree in biological science and six years of quality assurance or control experience related to clinical trials. Preferred candidates have experience with FDA inspections, technical writing, and cellular therapy manufacturing.
Be You.
Duke University’s Marcus Center for Cellular Cures has an immediate opening for a QA Regulatory and Compliance Associate in their GMP lab located at 2400 Pratt Street Durham, NC. This position is currently on – site.
The ideal candidate will have relevant knowledge and industrial experience in the field of bioprocess development for manufacture of cellular and tissue-based therapies and will have experience transferring processes to cGMP facilities for clinical or commercial manufacture.
They are expected to possess a high level of skill and experience with key bioprocess techniques and cGMP production including cell culture and bioreactor operation and scale-up, or experience from the Quality Assurance perspective for these processes.
Minimum Qualifications:
Education/Training
Work generally requires a bachelor's degree in a biological Science.
Experience
Work requires six years of experience quality assurance or quality control related to clinical trials.
A Master's degree in a related field may be substituted for 2 years of required experience or an equivalent combination of relevant education and/or experience.
Occupational Summary
Work Performed
Preferred Skills
The ideal candidate will have relevant knowledge related to working in a quality or compliance function within an FDA related cellular therapy manufacturing facility. A background in auditing and writing reports would be beneficial. The preferred candidate
would also have experience participating in FDA inspections, and other regulatory, accreditation and sponsor audits.
The ideal candidate is expected to possess experience within a manufacturing or quality assurance function with particular emphasis on the writing, review, and approval of deviations, CAPA’s, and change controls request. This position will primary be
writing reports thus a keen eye for detail and a background in technical writing would be ideal.
Other preferred skills include:
• Experience working with electronic QMS software
• Project management experience
• Excellent communication skills, both written and oral
• Ability to pay attention to detail
• Excellent organizational skills
• Outstanding interpersonal skills
• Excellent analytical skills, good judgment, strong operational focus
• Self-directed team player
• Concise Data Gathering
The preferred candidate will have experience with successfully seeing a product from process development to clinical trials and, if applicable, through commercial FDA-licensure. The preferred candidate would also have experience participating in FDA inspections, and other regulatory, accreditation and sponsor audits.
Choose Duke.
Join our award-winning team as identified by Forbes magazine as America’s Best Large Employer 2024 and be part of an inclusive culture that values excellence, innovation, and discovery. As an organization, we have exciting opportunities to be forward-thinking leaders in our field. We want talented individuals to join us, examine our current operations, and create innovative solutions that will revolutionize and enhance the way we approach our work.
Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines.
Beyond the engaging work, you'll also benefit from Duke's competitive benefits package including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.
Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $67,919.00 to USD $102,898.00. 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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