- GRAIL (Durham, NC)
- …grail.com . Grail's Clinical Compliance department is seeking a compliance expert to support compliant conduct of Grail's clinical studies and to support Grail's ... you'll collaborate cross-functionally to proactively manage both GCP and CDx regulatory risks, lead inspection readiness, and continuously improve quality standards… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …a timely manner. This position will also provide site representation for regulatory surveillance program. JOB RESPONSIBILITIES: Financial: Provide support in ... , Corporate or vendor audits and audit readiness related activities. + Support internal and external/ regulatory audits / inspections when required. Stakeholder:… more
- Duke Energy (Charlotte, NC)
- …specific job-related service information. + Assign preliminary accounts in customer systems for appropriate region-specific billing system and must obtain customer ... at 40+ words per minute (WPM)) + Knowledge of regulatory rules, regulations, inspections, and requirements. + Ability to...work extended hours, as well as mandatory overtime, to support higher call volumes. + Shift change occurs biannually,… more
- Merck (Wilson, NC)
- …of material throughout the plant + plant investigations + data compilation/ support for internal/external audits and regulatory inspections + SOP development ... but are not limited to: + Quality Assurance functions for plant wide systems /processes to include direct line support to production areas, deviations, product… more
- Fujifilm (Holly Springs, NC)
- …will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems . You will ... summary reports + Ensures documentation is accurate, complete, and compliant with regulatory expectations to support operational readiness + Drives a robust… more
- J&J Family of Companies (Wilson, NC)
- …, laboratory equipment lifecycle management - including analytical instrument qualification, systems and/or CSV support coordination. + Deep understanding and ... is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and… more
- Novo Nordisk (Clayton, NC)
- …across the organization, as well as in Corporate IT & Business units + Ensure systems & processes are compliant & meet regulatory & business requirements + ... compliant methods of working + Ensure that archive/retention procedures, strategies, and systems meet regulatory and data retention requirements + Follow all… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …internal and other regulatory audits. + Work in close collaboration and support with other members of the CMC team responsible for drug product development and ... with guidance of CQA. Execute and complete procedures and systems for RM, PM, FD and in process testing...and execution of stability study as per Quality and regulatory requirement. Timely complete testing and ensure compliance during… more
- Bank of America (Charlotte, NC)
- …enterprise-wide focus areasand activities across the CFO - US Regulatory Reporting organization, which includes governance, interpretation of report instructions, ... production and submission of OCC/FRB/FDIC US regulatory reports (eg FR Y-14,FR Y-9C,FFIEC 009, FR Y-15,...external audit or consulting + Experience in evaluating workflows/ systems / data mining + Experience with production of US… more
- ThermoFisher Scientific (Greenville, NC)
- …Work:** As an Engineer III, Validation, you will provide direct quality support through compliance, regulatory assessment, and validation activities. You will ... to achieve process improvements and efficiencies to address shortcomings in processes and systems . + Host and coordinate regulatory inspections performed by the… more