- Astellas Pharma (Sanford, NC)
- …equipment, instruments, utilities, clean rooms, computer systems , and manufacturing process. + Evaluate and approve qualification/ validation discrepancies ... ** Specialist , QA Validation (Onsite in Sanford,...activities across the site. This role ensures that all validation efforts comply with current Good Manufacturing … more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …Hybrid position based out of our RTP, NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout ... in the development of cGMP operating procedures that relate to process, computer systems , and equipment validation . + Assures compliance with SOPs upon… more
- Kelly Services (Winston Salem, NC)
- ** Manufacturing Specialist III - Cell Processing** **Location: Winston Salem NC** **Contract Role, 12 month long with potential to convert** **Hourly Pay Rates: ... performing critical product freezing and storage, and driving continuous improvement. The Manufacturing Specialist III is also responsible for mentoring team… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and oral) required to work across departments and management levels. + Successful Manufacturing , Quality Systems and Validation track record required. ... guidelines. + Provide leadership for the group and work with entry level Validation Specialist on developing and monitoring training at different intervals of… more
- Merck (Durham, NC)
- … /Six Sigma methodology. **Required Skills:** Audit Management, Automated Manufacturing Systems , Automation, Business Process Improvements, Communication, Data ... Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation . **Position Description:** The Senior Specialist , is a… more
- Fujifilm (Holly Springs, NC)
- …of Drug Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable ... **Position Overview** The QA Specialist , Operations is responsible for partnering in the...years' experience in a GMP environment * Experience in Validation , cGMP manufacturing operations and/or Quality oversight,… more
- Actalent (Sanford, NC)
- …impact. + Collaborate with cross-functional teams, including Engineering, Quality Assurance, Validation , and Manufacturing , to ensure timely and compliant ... Description We are seeking a detail-oriented and proactive Change Control Specialist to support the Engineering Compliance Group at a bio-pharmaceutical … more
- Actalent (Sanford, NC)
- …impact. + Collaborate with cross-functional teams including Engineering, Quality Assurance, Validation , and Manufacturing to ensure timely and compliant ... Job Title: Change Control Specialist Location: Sanford, NC Placement Type: Contract Duration:...support the Engineering Compliance Group at our client's bio-pharmaceutical manufacturing facility. This role is essential to ensuring that… more
- Actalent (Raleigh, NC)
- …regulatory impact. Collaborate with cross-functional teams (Engineering, Quality Assurance, Validation , Manufacturing ) to ensure timely and compliant execution ... Description We are seeking a detail-oriented and proactive Change Control Specialist to support the Engineering Compliance Group at our client's bio-pharmaceutical … more
- Fujifilm (Holly Springs, NC)
- …with Customer Relationship Management * Prior drug substance or manufacturing experience, including process validation , transfer, commercialization, and ... manufacturing support and troubleshooting. * Experience using quality systems (eg, deviation management system, change control, corrective and preventive action… more