- Insight Global (Durham, NC)
- Job Description This individual will lead and direct all QA activities supporting Facility Engineering, Validation and IT in a contract manufacturing organization ... systems, utilities, facilities, cleaning and process validation. Review and approve GMP documentation developed to support the delivery of key capital projects… more
- Amgen (Holly Springs, NC)
- …+ Maintain up-to-date EN/SICAR/Early Engagement (EE=new item) trackers and manage or lead small to medium projects. + Provide input for ANC representative to ... Continuous Improvement (CI) leads to help SUS improvement projects and provide/ lead use cases for continuous improvement projects. For example, improvements around… more
- ThermoFisher Scientific (St. Louis, MO)
- …lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, ... performed in Biosafety Cabinets + Attend and actively participate in MFG huddles + Lead /attend and actively participate in QA OTF Tier 1 huddles + Act as Quality… more
- Fujifilm (North Kingstown, RI)
- …production activities with schedule changes and operational needs. + Ensure GMP (Good Manufacturing Practices) compliance within the production team, maintaining ... compliance with safety standards, and promotion of best practices. + Lead team dynamics through effective team meetings, one-on-one communication, and… more
- Lilly (Indianapolis, IN)
- …ADCs, we are seeking a highly experienced and strategic Senior Director to lead our payload linker development efforts within the Antibody-Drug Conjugate (ADC) team. ... development and thrive in a collaborative and fast-paced work environment. + Lead and oversee CMC process development activities for novel payloads and drug-linkers… more
- Merck (Durham, NC)
- …area + Represent Operations on project teams as needed **Communication** + Lead and support daily (Tier) meetings to facilitate flow of information up/down ... does include working alternating weekends and holidays + Demonstrated ability to lead a team (ie experience leading directly as a supervisor/coach or indirectly… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. ... . The **Manager of Project Management** will own and lead in the management and successful delivery of assigned...years of leadership experience is preferred. + Experience in GMP related industry is preferred. + Professional Project Management… more
- Aerotek (Cincinnati, OH)
- …disassembling and cleaning equipment. You will work in compliance with a GMP environment, ensuring adherence to Standard Operating Procedures and Manufacturing Batch ... problems. + Process electronic batch records and transactions in SAP. + Lead and participate in continuous improvement initiatives. **Essential Skills** + Basic math… more
- Amgen (Holly Springs, NC)
- …for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations. In this vital role as a member of ... + Own and drive to completion Change Controls, CAPAs, and Deviations + Lead and support technical root cause analysis, incident investigations, and troubleshooting +… more
- Church & Dwight Co., Inc. (Vancouver, WA)
- …policies, safety policies and practices, quality standards, and Good Manufacturing Practices ( GMP ). + Responsible at all times for ensuring that tasks are performed ... food safety, quality, and regulatory guidelines. + Wear proper GMP and Personal Protective Equipment (PPE) attire for all...procedures. + Perform cleaning tasks as assigned by Packing Lead , Shift Lead , and/or Supervisor. + Act… more