- Kelly Services (Clayton, NC)
- …+ Documentation and data integrity + Laboratory operations + Regulatory compliance (GMP/ GxP ) + Budget planning and oversight + Employee relations and staffing + ... + Provide expert guidance to manufacturing and regulatory departments on GxP -related matters. + Make informed, independent decisions within the defined scope… more
- Lilly (Durham, NC)
- …processes. **Basic Requirements:** + 10+ years' experiencein the pharmaceutical industry in GxP roles, with several years Quality experience. + Bachelor's degree in ... Natural Science, Engineering, Pharmacy, or other Life Science-related field. **Additional Skills/Preferences:** + Proven ability to work in a matrixed organization with diverse teams and influencing areas not under direct control. + Strong strategic thinking… more
- Pfizer (Sanford, NC)
- …filtration equipment, and coordinate daily activities of Good Manufacturing Practices ( GxP ) production to meet supply chain needs. + Facilitate effective project ... meetings with internal team members and customers, and develop SPC charts for continuous process monitoring and control. + Manage project finances, provide information to support financial reporting requirements, and ensure process adjustments are incorporated… more
- Fujifilm (Holly Springs, NC)
- …large-scale operations model, including contributing to the site's digital roadmap for GxP process data management + Mentors employees and oversees their development ... to ensure the team is positioned for long-term growth and success + Partners with HR, Talent Acquisition, and other stakeholders to attract top talent while developing effective retention strategies + Evaluates team performance regularly, implements measures… more
- CREO (Durham, NC)
- …needs such as SaaS release management (eg change control and validation of GxP releases) for additional Client value. + Business Development and Account Management + ... Accountable for achieving the service lines financial growth targets, with a primary focus on securing new customers in the life sciences and healthcare sectors. + Proactively identifies opportunities to cross-sell other CREO services, including Cybersecurity… more
- J&J Family of Companies (Wilson, NC)
- …with the CSV Automation Lead and is responsible for supporting all GxP -Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ... ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. The position will support validation activities, take ownership of development and approval of validation documents… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …On-prem/cloud hybrid experience using Middleware tools + Hands-on experience in managing GxP & SOX solutions + Working experience with EDI/OTC/FSS/3PL's and trading ... partners + Working experience with pharama manufacturing processes + Hands-on DevOps & Agile delivery experience + Track record working in a fast paced, FDA regulated IT environment + Experience managing consultants and providing technical recommendations +… more
- Cytel (Raleigh, NC)
- …or functional requirements. + Ensure compliance with own Learning Curricula, corporate and/or GXP requirements. Here at Cytel we want our employees to succeed and we ... enable this success through consistent training, development and support. To be successful in this position you will have: + Bachelor's degree in Life Sciences, Health Informatics, or related field + 10+ years of progressive experience in clinical data… more
- US Tech Solutions (Wilson, NC)
- …meet tight deadlines and maintain a positive attitude. **Skills:** + Must have GxP Documentation experience + The documentation is used published for trainings + ... Must have experience with electronic document systems (Veeva Vault) + Knowledge of life cycle of documents + Quality Systems experience, the system itself and the documentation process + Experience with CAPA, highly desired + Change Control, highly desired +… more
- Allucent (Cary, NC)
- …+ 2 - 4+ years of relevant work experience + Basic knowledge of GxP + GDPR/HIPAA and applicable (local) regulatory requirements + Strong communication skills + ... Ability to translate guidelines, rules and regulations in clear and usable recommendations + Strong analytical skills + Strong written and verbal communication skills including good command of English language + Representative, outgoing and client focused +… more