- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more
- Actalent (Clayton, NC)
- …CFR Part 11, GAMP5, ISO, electronic records retention, configuration items list, FDA and ICH guidance documents. + Demonstrated experience using root-cause analysis ... techniques to solve problems. Work Environment This position requires on-site work in Clayton. Job Type & Location This is a Contract position based out of Clayton, NC. Pay and Benefits The pay range for this position is $50.00 - $75.00/hr. Eligibility… more
- Lilly (Durham, NC)
- …Goals + Understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and OSHA. + Excellent interpersonal, written and oral communication ... skills + Ability to travel up to 10% **Additional Preferences:** + Technical or Science degree preferred + Previous leadership/supervisory experience helpful + Career interests in Operations Leadership + Device Assembly or Packaging experience **Education… more
- Penn Medicine (Lansdale, PA)
- …with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, etc) Manage the day-to-day planning, operations and problem solving for ... assigned areas - ensure daily schedule, staffing needs, and performance metrics are met. Communicates changes appropriately. Develops and maintains APM templates and master schedules Oversight of AHIQA. Runs regular financial reports and works towards… more
- Actalent (East Windsor, NJ)
- …environment in the laboratory. + Ensure compliance with international regulations such as FDA and EMA. + Work collaboratively with R&D and production teams to ... support product development and release. + Provide technical support and training to junior team members or other departments. Essential Skills + 3-7 years of routine testing experience using HPLC and dissolution techniques. + Proficiency in working with solid… more
- Bristol Myers Squibb (Devens, MA)
- …flow and strong information security. + Ensure strict adherence to GxP, FDA , and other applicable regulatory standards in system implementation, validation, and ... operations. + Partner with internal stakeholders (lab users, engineers, QA, manufacturing) to clarify user needs, recommend scalable solutions, and drive digital innovation at the bench level. + Direct vendor relationships and manage contractors supporting… more
- Danaher Corporation (Seaford, DE)
- …complete service administration activities in a timely manner to follow ISO, FDA , and Leica policies. + Effectively communicate with internal colleagues and external ... customers within established time guidelines to meet customer's expectations. The essential requirements of the job include: + Associates' Degree with 1+ years of experience or equivalent military experience. + Travel throughout the district - this position… more
- Nature's Bakery (Hazelwood, MO)
- …will also be responsible for filing all paperwork in a manner that supports FDA compliance and audit preparedness at all times. + Handling Inbound and Outbound ... Paperwork The coordinator will interact with over the road drivers as well as member of other departments throughout the company. This role is expected to effectively communicate in a professional, respectful manner that promotes a positive atmosphere. +… more
- Actalent (Raleigh, NC)
- …in Environmental Monitoring and a working knowledge of the appropriate GMP and FDA regulations. The individual will be expected to have knowledge of LIMS (or ... equivalent system) and be able to identify trends and aberrant sample results. Prior experience compiling trending data is a plus. The individual in this role will also be required to complete investigations in a timely manner, make recommendations on… more
- Actalent (Branchburg, NJ)
- …production. + Carefully follow and accurately complete all procedures in accordance with FDA requirements, ensuring all documents are up to date. + Participate in ... cycle counts and review kit data to ensure product quality and consistency. + Assist Technical Services in troubleshooting any problems, facilitating sample and kit testing in response to customer complaints or requirements. + Interact with all other… more
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