- Astrix Technology (Ocean County, NJ)
- …+ Provide technical input during project discussions and client meetings. + Ensure compliance with all safety, quality , and regulatory standards. + Analyze and ... support process development, scale-up, technology transfer, and commercialization of pharmaceutical products with minimal supervision. This role contributes technical… more
- Parexel (Trenton, NJ)
- …and marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include ... and post-approval changes Cross-Functional Collaboration * Partner with manufacturing, quality , and external organizations to address CMC-related issues * Maintain… more
- Bayer (Newark, NJ)
- …meetings including program evaluation, required attendance and coordination of high quality meeting reports; + Identifies educational gaps and provides subsequent ... FDA guidance for distribution of scientific information; + Adherence to SOP and compliance guidelines for all external contacts; + Prepares and presents data to… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …+ Works in conjunction with the telephony services to support IP Telephony quality of service, and ensure proper configuration of network devices to support IP ... implementing VLANs, routing protocols, LACP, etc. + Experience in supporting IT operations in compliance with 21 CFR Part 11, COBIT 4, and J-SOX + Experience with… more
- Bristol Myers Squibb (Princeton, NJ)
- …coaching. **Internal/External Stakeholders** + **Internal** : Global Procurement Leadership, Compliance and Ethics, Global Quality , IT Operations, System ... Management (TPRM) is essential to safeguard patient safety, ensure regulatory compliance , and protect Bristol Myers Squibb's reputation by proactively identifying,… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …or Pharmaceutical regulated environment + Solid knowledge of relevant Quality /Regulatory standards (cGxP, CFR Part 11, etc.) + Proficiency in system development ... will report to the TGS Senior Director, Product Services and work with the Quality function as well as individual business units and other global functions to match… more
- Bristol Myers Squibb (Warren, NJ)
- …and retirement. Provide input and feedback for change strategy, qualification approach, compliance gaps, and risk mitigation. + Review and approve calibration plans, ... risk assessments, audit trail reviews, and user access reviews for CQV equipment. Compliance and Regulatory Responsibilities + Lead and support workflows related to … more
- System One (Princeton, NJ)
- …developers, QA professionals, and SMEs to support rapid development timelines without compromising quality or compliance . This is an ideal position for someone ... Lead and manage the validation team, ensuring systems meet compliance with GxP and 21 CFR Part 11. +...management experience. + Experience in a CRO, biotech, or pharmaceutical environment. + Familiarity with cloud technologies and web-based… more
- System One (Cranbury, NJ)
- …air, WFI, and clean steam systems + Solid understanding of cGMP and FDA compliance requirements in a manufacturing or pharmaceutical settin + Proven ability to ... personnel including hands-on support, equipment repair and upkeep, facility maintenance, and compliance with cGMP and safety regulations. This role requires a strong… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and global leadership to integrate international initiatives related to supply, quality , and/or compliance + Ensures customer understanding of BD-initiated ... member of the Technical Solutions Support team at BD Pharmaceutical Systems (PS) and plays a key role in...in quality assurance, quality control, quality systems, or regulatory compliance . Project management… more