- AbbVie (Florham Park, NJ)
- …a high degree of responsibility in maintaining Statistics department standards, GxP compliance, and best operating practices. + In collaboration with Medical ... Affairs, Clinical Statistics, Data Sciences, Statistical Programming, Market Access and other stakeholders, direct the assessment and evaluation of existing databases, both clinical studies and real-world databases, supervise the conduct of feasibility… more
- Sanofi Group (Morristown, NJ)
- …+ Experience in working within compliance (eg: quality, regulatory - data privacy, GxP , SOX) and cybersecurity requirements is a plus + Relevant cloud certifications ... are a plus **Education** : + Bachelor's and/or Master's degree in Computer Science, Information Systems, Software Engineering or similar field (Preferred) **Languages** : + English **Why Choose Us?** + Bring the miracles of science to life alongside a… more
- Sanofi Group (Morristown, NJ)
- …challenges and requirements of delivering solutions in this space. + Knowledge of GxP , HIPAA, and GDPR regulations and the ability to ensure compliance with these ... regulations in the design and implementation of patient solutions. + Experience in encryption, data masking and data anonymization techniques + Detail-oriented, customer-driven, and able to work well across time zones on a global team. + Ability to work… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations . Possesses strong collaboration, influencing and negotiation skills ... to work effectively with internal cross-functional group and external suppliers to meet the aggressive clinical study timeline and patient needs. . Leads through ambiguity, can assess options quickly and efficiently implement the best option in alignment with… more
- Cognizant (Trenton, NJ)
- …business systems analyst with a deep understanding of business processes under GxP , ISO, and regulatory compliance Knowledge of Mfg. Process Controls and Reporting ... program Awareness of Electronic Lot History Records using Camstar Software for Medical Device/ Pharma industries Implement and execute the shopfloor transaction using OpCenter Execution Discrete in Discrete manufacturing Industry Experienced in Camstar (V8.x)… more
- Capgemini (Raritan, NJ)
- …test cases, scripts, and validation protocols in alignment with company, GxP , and regulatory policies. + Collaborate with cross-functional teams to gather ... and analyse requirements and ensure that validated systems address user needs and acceptance criteria. + Execute validation testing, document findings and discrepancies, and work with PAS-X MES modeler and engineer teams to resolve issues identified during… more
- CGI Technologies and Solutions, Inc. (New Brunswick, NJ)
- …installation and / or configuration. -Act as an IT Technical Resource(s) for GxP systems undergoing SDLC validations. -Lock down of computer O/S to meet clients ... Data Integrity requirements. -Verify systems comply with clients IT Security Standards for the lab environment -Conceptualizing creative solutions, as well as documenting them and presenting/selling them to senior management. Confident and positive attitude,… more
- BeOne Medicines (Pennington, NJ)
- …experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). Previous experience in a manufacturing or ... operations environment. Strong experience with any two of the following platforms: Veeva, LIMS, CDS and/or other Quality platforms. validation practices (GAMP). Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other… more
- Integra LifeSciences (Princeton, NJ)
- …planning outputs for compliance and accuracy. **Compliance & Validation** Experience ensuring GxP , FDA, and other regulatory compliance in Life Sciences supply chain ... implementations. **Experience Highlights** : + Lead Oracle EBS ASCP R12.2 & Cloud Demand Planning implementations and rollouts Medical Device clients, optimizing global supply chain operations. + Worked on rolling out system configurations and enhancements… more
- BeOne Medicines (Pennington, NJ)
- …+ Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). + Strong experience with one of the ... following platforms: Siemens BAS, Rockwell DCS, DeltaV, Allen Bradley PLC, OSISoft PI historian, Kepware, Instrumentation and control panel hardware as required by the job. + Experience with computer systems validation practices (GAMP) + MS Project. **Other… more