- Novo Nordisk (Durham, NC)
- …core validation areas (packaging, API, cleaning, utilities, process, or computer validation ) required + Knowledge of statistical methods (hypothesis testing, ... compliant with regulations + Authority for product release + Quality oversight, review & approval of validation ...Validation , etc.) required + Experience with regulatory requirements computer system, such as 21 CFR Part 11, GAMP5,… more
- ThermoFisher Scientific (Greenville, NC)
- …food safety, and delivering COVID-19 solutions. **Location/Division Specific Information** The Computer System Quality Assurance Team provides quality ... Services Group (PSG) of Thermo Fisher Scientific, ensuring compliance to regulations for computer system validation (CSV) and assurance with respect to data… more
- Lilly (Concord, NC)
- …manufacturing required + Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation ... Quality SME with minimal supervision + Proficiency with computer systems including SAP, Trackwise, MES etc. + Responsible...+ Previous use of KNEAT - or other electronic validation software + Previous technical writing experience Lilly is… more
- Lilly (Concord, NC)
- …manufacturing required + Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation ... through philanthropy and volunteerism. **What You'll Be Doing:** The Quality Assurance Representative is responsible for demonstrating leadership, teamwork, and… more
- Novo Nordisk (Durham, NC)
- …process confirmation on shop floor. Handle release of raw materials & provides quality oversight, review & approval of validation activities associated with ... of the Batch Review Processes required + Understanding of validation preferred + Understanding of quality management...Excellent written & verbal communication skills required + Basic computer skills in MS Office, MS Project, PowerPoint, etc.… more
- Lilly (Concord, NC)
- …+ Investigation and deviation management experience. + Demonstrated proficiency in computer system validation . + Experience with compliance requirements and ... **Key Objectives/Deliverables:** + Performs and/or supports the laboratory with the validation of laboratory equipment and software systems. + Supports the… more
- Lilly (Durham, NC)
- …representative of the Quality function. + Approve commissioning qualification / validation documents for computer systems and equipment to ensure compliance ... skills. + Demonstrate knowledge and understanding of manufacturing process and Quality Systems. + Proficiency with computer systems including Microsoft… more
- Jabil (Hendersonville, NC)
- …compliance with quality standards. You will perform measurement, inspection, and validation tasks, while also training personnel on quality procedures and ... Shift (8 am - 8 pm, rotating) How will you make an impact? As a Quality Technician II, you will collaborate with Manufacturing, Quality , and Quality … more
- Cardinal Health (Raleigh, NC)
- …as: cost of quality , analytical metrics and / or statistics, trending, quality planning, validation , CAPA and problem solving. + Works cross-functionally and ... remain on the therapy they need for a better quality of life. Our diverse expertise in pharma, payer...to high-speed internet. We will provide you with the computer , technology and equipment needed to successfully perform your… more
- Lilly (Durham, NC)
- …qualification / validation documents for equipment to ensure compliance with quality standards. + Liaison with Lilly support groups and external partners to ... Society for Quality (ASQ) or CSQA Experience + Proficiency with computer systems including Microsoft office products. + Proven ability to work independently or… more