- Lilly (Concord, NC)
- …the project phase, the Operations Associate (OA) will support commissioning, qualification, and validation of the Parenteral (PAR) areas as well as lead / assist in ... + Understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and OSHA, or other similar groups + Excellence in;… more
- Novo Nordisk (Clayton, NC)
- …Wash/Sterilization, Filling, & media preparations through documentation, start-up and validation activities for a new production facility. Relationships Reports to ... & other documents + Assist in the start-up and validation of new equipment + Review standards to maintain...+ Minimum two (2) years of experience in an FDA regulated environment required + Aseptic processing experience required… more
- Cambrex High Point (Durham, NC)
- …data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss ... chemistry. + Understands the chemical properties relating to method development, qualification / validation and troubleshooting. + Able to comply to SOPs and basic… more
- Fujifilm (Holly Springs, NC)
- …analytical method TT and execution including method verification, transfer and validation * Interfaces with customers and program management to identify analytical ... * Ensures compendial method oversight and scientific guidelines (eg ICH, EMA, FDA , etc.) * Supports regulatory requests and inspections * Supports the QC… more
- Lilly (Durham, NC)
- …group (primarily automation) supporting asset delivery, process development, commissioning, qualification, validation and startup of the logistics area as well as ... supporting systems through user requirements, design, build, commissioning, qualification, validation , and subsequent operation. + Provide leadership and develop… more
- Fujifilm (Holly Springs, NC)
- …experience * 1-3 years' experience in a GMP environment * Experience in Validation , cGMP manufacturing operations and/or Quality oversight, in an FDA regulated ... knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software **Physical and Work Environment Requirements:** Ability to discern… more
- Fujifilm (Morrisville, NC)
- …experience in GMP QA or similar role **Preferred Requirements** + Experience in Validation , CGMP Manufacturing Operations and/or Quality oversight in an FDA ... regulated facility **WORKING CONDITIONS & PHYSICAL REQUIREMENTS** Will work in environment which may necessitate respiratory protection. X No Yes May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing… more
- Cambrex High Point (High Point, NC)
- …data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss ... to read and execute compendial methodologies + Strong understanding of current FDA and cGMP regulations + General knowledge of chemistry and scientific calculations… more
- Novant Health (Winston Salem, NC)
- …Supply Chain Security Act (DSCSA), recall documentation, board of pharmacy rules and FDA and DEA regulations. The Manager of Procurement and Inventory will also ... + Ability to successfully complete generic and department-specific skills validation and competency assessment. + Strong verbal, written, and presentation… more
- Sumitomo Pharma (Raleigh, NC)
- …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more