- Lilly (Durham, NC)
- …delivered solutions and processes; work closely with system SMEs and site Quality while supporting computerized systems verification processes in a GxP environment. ... and be able to oversee and lead activities to ensure that automated cGMP equipment, facilities, and utilities perform as intended. + Lead investigations of… more
- United Therapeutics (Research Triangle Park, NC)
- …Responsibilities for this role also include oversight and leadership of the Change Control , Quality Event, and CAPA programs and supporting management during ... for GxP events + Interact regularly with peers and senior management across multiple functional groups (eg, Research and...stressful situations, and deadlines + Demonstrated expertise with FDA Quality System regulations and cGMP , ISO 13485,… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …observations and well versed with Regulatory requirements. Under the direction of the Senior Director of Quality , this position is also responsible for ... which includes, but is not limited to, the following systems: Document Control , Electronic Quality Management Systems (Investigation, Change Control ,… more
- Cambrex High Point (Durham, NC)
- …customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities ... Together with our customers, we aim to improve the quality of life for patients around the world. Start...Duties and Responsibilities + Execute analytical methods for in-process control , release testing and stability monitoring of bulk drug… more
- ThermoFisher Scientific (Greenville, NC)
- …leadership required. + Deep knowledge of cGMPs and pharmaceutical contract manufacturing, Quality Assurance, Compliance, Quality Control and Regulatory ... strong dedication to customer happiness, you'll provide technical leadership and Quality oversight for our Solid Dose/Animal Health Manufacturing and Sterile… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …and execution of SAP transactions15. Communicate with Materials Management, Production Operations, and Quality Control on a daily basis to ensure the timely and ... the production and packaging of BacT/ALERT bottles in a cGMP compliant manner. The position may perform or assist...all of our customer requirements16. Assess when manufacturing or quality issues require escalation to senior staff… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …and execution of SAP transactions + Communicate with Materials Management, Production Operations, and Quality Control on a daily basis to ensure the timely and ... the production and packaging of BacT/ALERT bottles in a cGMP compliant manner. Responsibilities: + The position may perform...as assigned by manager 5. Assess when manufacturing or quality issues require escalation to senior staff… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …wide. + Ensures responsible group remains compliant with Safety, Performance Development, Quality Stewardship, SOP read and Review, and cGMP training ... and regions. **Location: Clayton NC** **Summary:** The Validation Manager II, is a senior Manager role within the department. This person is responsible for managing… more
- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a lead ... and services in more than 110 countries and regions. Summary: The Senior Operations Supervisor plays a critical leadership role in the day-to-day operations… more
- Actalent (Sanford, NC)
- …Qualifications + Assay development + Method validation + Method development + Method transfer + cGMP compliance + Quality control + Familiarity with LIMS + ... Title: Scientist - Plate Based Job Description The Scientist will support the Quality Control Method Transfer and Validation team by performing method validation… more