- ThermoFisher Scientific (Greenville, NC)
- …Description** Join Thermo Fisher Scientific Inc. as an outstanding GCP Compliance Oversight Manager and play a crucial role in ensuring the flawless execution of ... + Bachelor's degree preferred + Regulatory Authority Inspections Experience ( FDA , MHRA, HEALTH CANAD, EMEA, etc.) + Experience leading cross-functional… more
- Kelly Services (Clayton, NC)
- **Position Title:** Quality Control Environmental Monitoring Manager **Location:** Clayton, NC **Schedule:** Monday - Friday | 8:00 AM - 5:00 PM **Salary Range:** ... scope of responsibility. + Plan, delegate, and prioritize tasks to meet project timelines and budgets. + Represent the department during internal and regulatory… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... ability to network, collaborate, and identify operational efficiency opportunities + Strong project management and operations skills + High attention to detail and… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …guidelines of bioMerieux's Quality System. Adhere to Regulatory requirements, including FDA , ISO, Legal, Ethical, and bioMerieux-specific procedures. + Source a ... + Design, lead, and implement cost savings projects based on a structured project /savings roadmap. + Follow current Lean and Six Sigma, Kaizen Continuous Improvement… more
- J&J Family of Companies (Wilson, NC)
- …site wide initiatives or other projects as needed in the capacity of a project manager or a subject matter expert. Conducts technical and validation studies. ... startup and technical training as required. + Serves as project manager for the change process and...Expert (SME) during internal and external regulatory audits (including FDA , EMEA). + Maintains various databases of production and… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... holidays) on a rotational basis + Participation in Change Manager Role on a rotational basis + Excellent written...medical industry compliance regimes and controls a plus (ie FDA 21CFR 11, HIPAA/HITECH) + Present ideas and information… more
- Cambrex High Point (Durham, NC)
- …workflows for drug substance and drug product. Reporting to the ( Manager , Associate Director, or Director), the Analytical Services Supervisor will provide ... fast-paced work environment. The supervisor will be responsible for operational project planning including resource allocation, project oversight, technical… more
- Fujifilm (Raleigh, NC)
- …on systems within a service area as directed by the Area Service Manager . **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to ... Performs other duties as assigned by the Area Service Manager . + Comply with all applicable US Food and...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Control (QC) Lab at the Monroe manufacturing facility, reporting to the QC Manager . Primary responsibilities for this position will be: perform QC analysis in ... the Revenue and Capex Budget as per spent analysis project . + Execute and maintain quality system controls to...to align with corporate guidelines. + Comply with applicable FDA and international regulatory laws/standards and the Code of… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …and goals within the assigned region + Acts as the Subject Matter Expert, Project Manager or Process Owner on assigned Global HSE programs Education, Skills, ... + In-depth knowledge of global HSE regulations and standards (OSHA, EPA, ISO 14001/45001, FDA QSR, EU MDR, etc.). + Experience in building and improving a Health… more