- Novo Nordisk (Durham, NC)
- …Review & approve documentation for Quality approval - components/raw material, batch records , change control requests, deviations & validation documents + ... Position Perform quality review & approval of Batch Production Records (BPRs), Change Requests (CR's),...presence & process confirmation on shop floor. Relationships Manager, Quality Assurance . Essential Functions + Ensure site… more
- Merck (Durham, NC)
- …harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion. Project ... **Position Responsibilities Could Include** : + Reporting to the Quality Assurance Organization, will independently manage project...environmental monitoring data. + Perform review of process simulation batch records . + Perform Quality … more
- Lilly (Concord, NC)
- …want to miss! Responsibilities: The Quality Assurance Floor Support Specialist is responsible for providing QA oversight to GMP operations. The role ... startup, commissioning and qualification of the Concord site. The QA Floor Support Specialist will demonstrate teamwork...+ Review and approve GMP documentation such as electronic batch records , logbooks, etc. + Troubleshoot and… more
- Cardinal Health (Raleigh, NC)
- **_What Quality Assurance contributes to Cardinal Health_** Quality Assurance is responsible for developing and implementing a compliant and cost ... tasks and projects + May act as the primary Quality Assurance Representative for site activities +...for site activities + Performs review and approval of batch records , materials, and associated documentation for… more
- Fujifilm (Holly Springs, NC)
- …and procedures * Provides QA support of DSM tasks such as o Batch Record and Solution Lot Record review, including exception-based oversight using ... **Position Overview** The QA Specialist , Drug Substance Manufacturing (DSM)...**Preferred Requirements** * 2+ years of experience in GMP Quality Assurance and/or similar role * Experience… more
- Fujifilm (Holly Springs, NC)
- …processes and procedures * Provides QA support of DSM to include: a. Batch Record and Solution Lot Record review, including exception-based oversight ... **Position Overview** The QA Specialist , Operations (Nights) is responsible...**Preferred Requirements:** * 2+ years of experience in GMP Quality Assurance and/or similar role * Experience… more
- Lilly (Concord, NC)
- …through philanthropy and volunteerism. The Quality Assurance Floor Support Specialist is responsible for providing QA oversight to GMP operations. The ... the start-up and qualification of the Concord site. The QA Floor Support Specialist will demonstrate teamwork.... Review and approve GMP documentation such as electronic batch records , logbooks, etc. . Support creation… more
- Merck (Durham, NC)
- …produce life-saving medicines and vaccines, including our HPV vaccines. The Quality Specialist provides guidance/direction of resources and equipment pertaining ... and/or customer needs to identify solutions. **FUNCTIONAL EXPERTISE:** The Quality Specialist will be responsible for comprehensive...procedures. + Review and approve BOM changes and Master Batch Records . + Review and approve Operations,… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …POSITION SUMMARY: The IPQA Specialist is a member of the Manufacturing Quality Assurance department at the Monroe manufacturing facility, reporting to either ... IPQA Specialist Department: QA Manufacturing Location: Monroe,...+ Ensure compliance with Standard Operating Procedures (SOPs), Forms, Batch Production Records , Protocols, as needed. +… more
- Fujifilm (Holly Springs, NC)
- …works closely with Quality Control, Analytical Development, Manufacturing and Quality Assurance to ensure compliance with GMP requirements **Company ... **Position Overview** The Sr. Specialist 1, QC LIMS supports the Laboratory Information...LIMS training, technical support, problem reporting and resolution(s) to Quality Control laboratory, QA , AD and Manufacturing… more