- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …Salary Range: Dependent on Qualifications/Experience Position Summary/Description: The purpose of the Regulatory Associate Lead is to facilitate the conduct ... regulatory meetings, and signing off on timecards for Regulatory staff * Taking a lead role in activation of new oncology clinical trials, including… more
- Actalent (Durham, NC)
- …flow filtration (TFF). + Work within a GMP facility, ensuring compliance with regulatory standards. + Collaborate with team members and other departments to achieve ... production goals. + Assist in authoring and reviewing manufacturing documents. Essential Skills + 3-5 years of experience within a GMP facility. + Proficiency in operating bioreactors. + Experience with cell splits and TFF. + Exposure to document authoring in… more
- Lilly (Durham, NC)
- …groups to support event management, change controls, etc. The Senior Operations Associate will lead investigations and drive implementation of actions associated ... this position is $64,500 - $140,800 The Senior Operations Associate will report to the Formulation/Material Preparation Operations Manager....area tours to support business reviews and / or regulatory audits + Trained as a Lead … more
- United Therapeutics (Research Triangle Park, NC)
- …preclinical studies to ensure the successful submission and approval of a drug product by regulatory agencies. This is a hybrid position with 4 days a week onsite in ... Development Manager and/or Program Head to coordinate, manage, and lead the overall execution of clinical studies or group...and results; Work with other internal functional areas (eg, Regulatory , Safety, Data Management) to support the study +… more
- Lilly (Durham, NC)
- …who are determined to make life better for people around the world. Associate Director - Quality Assurance (QA) Packaging is responsible for the staffing, training, ... and Packaging (DAP) production area at Lilly RTP. The Associate Director will help build a strong quality culture...Director will help build a strong quality culture and lead the QA team for oversight and support of… more
- Lilly (Durham, NC)
- …who are determined to make life better for people around the world. Associate Director Quality Assurance (QA) Parenteral is responsible for the staffing, training, ... dispensing, equipment preparation, formulation, filling and visual inspection. The Associate Director will help build a strong quality culture...Director will help build a strong quality culture and lead the QA team for oversight and support of… more
- RWE Clean Energy (Nathalie, VA)
- …**Functional area:** Health, Safety & Environment **Remuneration:** Exempt As the **Senior Associate in HSSE Operations** , your primary responsibility will be to ... Pathogens); supports multiple office and field work sites **Qualifications:** + Associate 's or Bachelor's degree in Occupational Health, Safety, and/or Environmental… more
- Banfield Pet Hospital (Durham, NC)
- …OF JOB PURPOSE AND FUNCTION The primary purpose and function of the Shift Lead is to perform the duties of a CSC and/or veterinary assistant/technician, as well ... always has leadership onsite to support associates and clients. The Shift Lead will help coordinate and guide the paraprofessional staff and support hospital… more
- Lilly (Durham, NC)
- …- $46.88 The Lead Technician - Manufacturing PMX will report to an Associate Director of Packaging Operations. The Lead Technician - Manufacturing PMX will ... groups to support event management, change controls, etc. The Lead Technician - Manufacturing PMX will also assist the...all HSE Goals + Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and… more
- Actalent (Durham, NC)
- Job Title: Associate Director of Centralized MonitoringJob Description We are seeking an Associate Director of Centralized Monitoring who will serve as a Subject ... understanding Key Risk Indicators (KRIs), and performing as the Clinical Team Lead (CTL) of the centralized monitoring team. This role involves oversight of… more
- Lilly (Durham, NC)
- …to end user functionality and to system compliance with company and regulatory requirements. Responsibilities will involve interacting with global and local IT ... the validated state of software-based computerized systems in use in the laboratory. + Lead site deployment and upgrades of QC laboratory IT systems such as Empower,… more
- IQVIA (Durham, NC)
- …statistical oversight for clinical trials, including: + Support and mentor lead statistician. + Perform senior level review of biostatics deliverables, including ... mentoring, training, and statistical support for Biostatistics staff. + Serve as lead statistician for one or more clinical trials, including: client interface,… more
- IQVIA (Durham, NC)
- …demonstrates IQVIA's credibility with clients, furthering the R&DS business. The Associate Therapeutic Strategy Director will take ownership of high-level client ... and data science experts to determine the optimal solution, project design and lead a cross-functional team in proposal development through to award + Assigned to… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …as hydrology, environmental justice, and data science. This position will 1) lead operationalizing existing remote sensing of water quality workflows and integrating ... of how remotely sense water quality data can be combined with key regulatory , river access, and socioeconomic data to improve decision making and identify… more
- Lilly (Durham, NC)
- …better for people around the world. **Organization Overview:** The QA Sterility Assurance associate is a member of the Quality Assurance team and teaches, mentors, ... ensuring they are aligned with all appropriate quality standards and current regulatory and industry expectations. This individual will participate in regulatory … more
- Lilly (Durham, NC)
- …Objectives/Deliverables:** + Enforce compliance to all procedures, methods, and other regulatory commitments as relating to EM, as well as applicable production ... Minimum 4 years of experience in Environmental Monitoring + Associate degree OR High School Diploma/GED with 4+ years...Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable. + Understanding of regulatory … more
- Lilly (Durham, NC)
- …to make life better for people around the world. The Quality Assurance Associate for Materials Management is responsible for the site parenteral & device materials ... management systems. The Materials Management associate provides Quality Oversight for the suppliers and materials utilized by the site. This position supports all… more
- Lilly (Durham, NC)
- …focus on Automated Warehouse operations. This role reports directly to the Associate Director Quality - DAP and Warehouse. The Quality Assurance Representative ... providing support during preparation for Pre-Approval/General Inspections by various regulatory agencies. **Key Objectives/Deliverables:** + Responsible for adhering to… more
- Walmart (Danville, VA)
- …performance. Ensures people processes (for example, selection, development, performance evaluation) lead to effective associate performance and desired results ... respects, embraces, and values diversity in others. Manages Pharmacy Operations: Conducts Associate meetings to identify and respond to their needs, concerns, and… more
- Merck (Durham, NC)
- …supporting the manufacturing process. Individual will possess the ability to cooperatively lead a team, train others and contribute to and implement process ... and/or multi-stage refrigeration systems) + Required Experience andFamiliarity of regulatory requirements in accordance with GMP manufacturing operations **Preferred… more