- US Tech Solutions (Branchburg, NJ)
- …06+ months contract** **Job Description:** + Responsible for maintaining compliance with FDA , AATB, international and state regulations during the second level ... quality review of all **tissue donor** files for tissue...and distributed products, triggering escalation procedures and evaluation for regulatory action. + The chart review is critical, and… more
- Actalent (East Windsor, NJ)
- …in our laboratory. You will work under prescribed procedures, ensuring quality and accuracy in quantitative analysis and environmental monitoring. You will ... in-process, finished bulk, finished product, and stability products in an FDA -regulated lab environment. + Utilize analytical instruments such as HPLC, GC,… more
- United Therapeutics (Trenton, NJ)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... rides within field regions with direct reports to evaluate regulatory compliance and abilities to deliver 'best in class'...Ability to lead region in delivery of consistent and quality education to hospitals and healthcare professionals + Ability… more
- Actalent (Hackensack, NJ)
- …daily with Principal Investigators, Research Nurse Coordinators, Sponsors, Regulatory Specialists, and Contract Research Organizations. + Coordinate preparation ... forms, monitoring plans, and validation plans. + Oversee submission of IND Applications to FDA as needed. + Design case report forms and liaise with data analysts… more
- NJ Sharing Network (New Providence, NJ)
- …needs and develops hospital service plans to ensure awareness, education and quality improvement of donor services. Develops goals and action plans in collaboration ... current knowledge of the donor process and the hospital regulatory environment (ie Department of Health and Human Services...Medicare and Medicaid Services (CMS), Food and Drug Administration ( FDA ) and New Jersey State Department of Health.) +… more
- Bristol Myers Squibb (Summit, NJ)
- …supervision of Warehousing Operations Management. Material Handlers must adhere to regulatory requirements while performing job functions. Job duties are performed ... shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. **Shifts Available:** Sunday to… more
- MTF (Edison, NJ)
- …Assist with UAT planning and execution using policies, procedures, and technology related regulatory practices ( FDA 21 CFR 11 -validated systems, etc.). Ensure ... criteria. + Ensure Pro activeness rather than Re activeness. Delivering high quality results in a timely fashion. + Responsible for troubleshooting issues to… more
- Fujifilm (Trenton, NJ)
- …States. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... adapt to rapidly evolving situations and needs + Strong commitment to delivering high- quality work and upholding HCUS values. + Proficiency in Microsoft Word, Excel,… more
- US Tech Solutions (Branchburg, NJ)
- …as critical care. **JOB SUMMARY:** * Responsible for maintaining compliance with FDA , AATB, international and state regulations during the second level quality ... suitability and distributed products, triggering escalation procedures and evaluation for regulatory action. **Education and Experience** NJ RN license from an… more
- Kedplasma (Cinnaminson, NJ)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... of units/samples into freezer per SOPs to ensure product quality . + Ensures only one plasma unit and samples...are available as needed. + Follows all SOPs and regulatory policies and procedures, including the employee handbook. +… more