Senior Quality Assurance Specialist, RTP
1 week ago
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
We are looking for a Senior Quality Assurance Specialist to join the QA team who will support all activities related to the quality management system for our RTP Laboratory.
Responsibilities
- Support the Clinical Laboratory to ensure CAP/CLIA/FDA regulatory compliance in all aspects of laboratory operations.
- Maintain CLIA certification, CAP accreditation and State licensure for the clinical laboratory as required.
- Lead, coordinate and support various QA activities such as:
- Maintenance of training plans and training records, including job descriptions and CVs
- Record Retention for Lab Documents including onsite and offsite storage management.
- Act as Administrator of multiple MediaLab Modules supporting CAP compliance such as Personnel Documentation, Compliance/CE, Inspection Proof and others as applicable.
- Author and reviews SOPs/policies, as well as verification/validation plans and reports.
- Conduct laboratory walkthroughs and CAP self-inspections for the clinical laboratory. Lead inspection readiness efforts and host inspections as needed.
- Track proficiency testing order, participation and performance.
- Identify trends and provide metrics to drive root cause analysis and corrective actions to prevent the recurrence of quality issues.
- Responsible for processing and managing issues/incidents that include deviations, NCs, and CAPAs, as well as ensuring compliance to FDA 21 CFR 820, ISO 13485, CAP/CLIA and other applicable quality system regulations and standards.
- Participate in process improvements to the quality management system framework by helping identify areas for improvement, simplification, and standardization, ensuring that the various systems are streamlined and aligned.
- Perform other job-related duties, as assigned.
- Bachelor's degree required
- Minimum of 4+ years of related knowledge and experience
- Highly organized and systematic, superb attention to detail and ability to complete tasks with a high degree of accuracy
- Strong interpersonal skills in the areas of written and verbal communication
- Self-motivated, organized, able to prioritize and organize time effectively
- Experience working with individuals to perform root cause investigations and to implement effective corrective actions
- Previous experience in a clinical lab regulated by CAP/CLIA is highly desirable. Experience in the FDA regulated industry - medical devices or IVDs is a plus.
#LI-Hybrid
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
-
Manufacturing Quality Assurance Associate
3 weeks ago
Wilmington, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Manufacturing Quality Assurance Associate
4 weeks ago
Wilmington, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor s degree or higher in a scientific or engineering discipline...
-
Manufacturing Quality Assurance Associate
4 weeks ago
Wilmington, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor s degree or higher in a scientific or engineering discipline...
-
Manufacturing Quality Assurance Associate
3 weeks ago
Wilmington, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor s degree or higher in a scientific or engineering discipline...
-
Manufacturing Quality Assurance Associate
4 weeks ago
Wilmington, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Manufacturing Quality Assurance Associate
4 weeks ago
Wilmington, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Manufacturing Quality Assurance Associate
4 weeks ago
Wilmington, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Sales Specialist
3 weeks ago
Wilmington, United States Discovery Senior Living Full timeJob DescriptionJob DescriptionAbout Discovery Senior LivingDiscovery Senior Living ranks prominently among the 5 largestsenior housing providers in the US, and is nationally renowned for designing,developing, marketing, and operating a multi-brand portfolio of upscale, luxurysenior-living communities. With over 250 communities in nearly 40states, and 15,000...
-
Sales Specialist
2 weeks ago
Wilmington, United States Discovery Senior Living Full timeAbout Discovery Senior Living Discovery Senior Living ranks prominently among the 5 largestsenior housing providers in the US, and is nationally renowned for designing,developing, marketing, and operating a multi-brand portfolio of upscale, luxurysenior-living communities. With over 250 communities in nearly 40states, and 15,000 dedicated employees,...
-
Sales Specialist
4 weeks ago
Wilmington, United States Discovery Senior Living Full timeJob DescriptionJob DescriptionAbout Discovery Senior LivingDiscovery Senior Living ranks prominently among the 5 largestsenior housing providers in the US, and is nationally renowned for designing,developing, marketing, and operating a multi-brand portfolio of upscale, luxurysenior-living communities. With over 250 communities in nearly 40states, and 15,000...
-
Quality Assurance Manager
3 weeks ago
Wilmington, United States Juanita's Foods Full timeDescription: **Job Summary**: Under the guidance and direction of the Director of Quality Assurance, the Quality Manager will implement Food Safety & Quality Assurance programs to ensure compliance of products and processes to corporate and regulatory requirements. The incumbent will also be responsible for overseeing HACCP, SQF, FDA, USDA and FMSA programs,...
-
Quality Assurance Specialist
2 weeks ago
Wilmington, United States Noramco, Inc. Full timeSpecialists in controlled substance development and manufacturing, Noramco is a partner to the pharmaceutical industry: - Delivering DEA-compliant security and production capacity, from kilos to multi-ton supply - Formulation-friendly particle size grades and extended technical packages - Supporting world-class supply security of controlled...
-
Quality Assurance Manager
2 weeks ago
Wilmington, North Carolina, United States The Judge Group Full timeWho We AreFedUp Foods, one of the nation's early producers of kombucha through the Buchi brand, and one of the largest functional beverage manufacturers in America, offers a diverse portfolio of organic private label functional beverages for top global retailersPosition SummaryAs the Quality Assurance Manager, you will be part of the core team responsible...
-
Quality Assurance Inspector
1 week ago
Wilmington, United States Sobieski Full timeQuality Assurance Inspector - New Home ConstructionSobieski Mechanical Contractors, Inc. of Newark, DE market is looking to hire a full-time Quality Assurance Inspector for our Residential New Construction Division. The successful Quality Assurance Inspector will verify HVAC systems were installed correctly, ensuring compliance with quality specifications...
-
Quality Assurance Inspector
2 weeks ago
Wilmington, United States Sobieski Full timeJob DescriptionJob DescriptionQuality Assurance Inspector - New Home ConstructionSobieski Mechanical Contractors, Inc. of Newark, DE market is looking to hire a full-time Quality Assurance Inspector for our Residential New Construction Division. The successful Quality Assurance Inspector will verify HVAC systems were installed correctly, ensuring compliance...
-
Quality Assurance Inspector
3 weeks ago
Wilmington, United States Sobieski Full timeJob DescriptionJob DescriptionQuality Assurance Inspector - New Home ConstructionSobieski Mechanical Contractors, Inc. of Newark, DE market is looking to hire a full-time Quality Assurance Inspector for our Residential New Construction Division. The successful Quality Assurance Inspector will verify HVAC systems were installed correctly, ensuring compliance...
-
Quality Assurance Supervisor
4 weeks ago
New Wilmington, United States Dairy Farmers of America Full timeResponsible for plant adherence to Good Manufacturing Practices (GMP) regulations and Sanitation Standard Operating Procedures (SSOP). Duties and Responsibilities: 1. Conduct GMP training for new employees as well as the monthly plant employee traini Quality Assurance, Assurance, Supervisor, Manufacturing, Business Services, Sanitation
-
Quality Assurance Technician
7 days ago
Wilmington, United States Sirtex Full time**Company Description** Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients...
-
Quality Inspector
1 month ago
Wilmington, United States Stratosphere Quality Full timeSummary of Responsibilities Join the Stratosphere Quality Team! Stratosphere Quality cultivates a positive organizational work environment, where employees are compelled to perform their best. Our team enjoys rewarding and meaningful work in a wide range of manufacturing work environments. Begin a rewarding career today and envision yourself...
-
Quality Inspector
4 weeks ago
Wilmington, United States Stratosphere Quality Full timeSummary of Responsibilities Join the Stratosphere Quality Team! Stratosphere Quality cultivates a positive organizational work environment, where employees are compelled to perform their best. Our team enjoys rewarding and meaningful work in a wide range of manufacturing work environments. Begin a rewarding career today and envision yourself...
