- Vestis Services (Charlotte, NC)
- …Experience, Automation, Material Handling Equipment/Processes, etc. + Knowledge of OSHA, FDA /Food Handling, HAACP, ISO 9000 is preferred + Demonstrated ability to ... execute projects in fast paced and dynamic environments using team-based, data-based approach + Demonstrated ability to coach, teach, and mentor technical and non-technical knowledge to hourly and salaried employees to drive business results + Must have a team… more
- Cytel (Raleigh, NC)
- …maintain relationships with senior stakeholders, including regulatory agencies (eg, FDA , EMA), key opinion leaders, and executive-level client personnel. ... **Scientific & Analytical Leadership** + Oversee and contribute to Pop-PK and PK/PD modeling, non-compartmental analysis (NCA), and broader QPP analytical activities. + Provide mentorship, technical oversight, and direction to consultants and analysts,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …or GED + One year of experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is required. + Experience working with cGMPs and Industry Standards ... + Experience in reading, understanding, and following Standard Operating Procedures **KNOWLEDGE, SKILLS, ABILITIES** 1. Possess good verbal and written communication skills 2. Possess basic math skills (addition, subtraction, division, multiplication). 3. To… more
- CSL Plasma (Greensboro, NC)
- …disconnect. 2 In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines performs venipuncture to begin pheresis process. 3 Evaluates vein performance ... of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the process a positive… more
- Norstella (Raleigh, NC)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... Norstella helps clients make decisions faster and with greater confidence. Norstella's investments in AI are transforming how data is consumed and decisions are made, disrupting inefficient legacy workflows and helping the industry become more efficient,… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable S. Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations and standards. **Qualifications:** + Bachelor's or Associate's degree in Business Administration or related field of study. + Minimum 2 years contract experience (Medical Service experience a plus). + Exceptional… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. **Qualifications:** + High School Diploma or equivalent is required. + Bachelor's degree in business, marketing or related quantitative disciplines preferred. + Minimum of 2 years of field sales or clinical… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …Auditor, Manager or Engineer a plus. * Superior knowledge of US cGMPs and FDA guidance. * Superior knowledge of EU GMPs, Annexes and ICH Guidance's and International ... Standards (Risk Management, ICH 8, 9, 10) * Knowledge of drug product manufacturing, packaging, laboratory, and warehousing operations. **Desirable** * Experience in SAP * Experience in sterile manufacturing * Previous experience in managing teams Third Party… more
- Merck (Raleigh, NC)
- …management, communication, and networking skills + A thorough comprehension of FDA , OIG, HIPAA, and other ethical guidelines, laws, and regulations relevant ... to the pharmaceutical industry and its customers + Ability to organize, prioritize, and work effectively in a constantly changing environment + Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Teams, OneNote) + Familiarity with… more
- Stryker (Charlotte, NC)
- …team members to include 3rd party vendors conform to organizational and FDA policies and procedures. + Provides day-to-day guidance for project activities; actively ... works to promote and recognize project team performance. + Provides detailed and accurate weekly revenue forecasting updates to higher level management outlining revenue recognition for a monthly, quarterly, and annual basis. + Other duties as assigned by… more