- Kelly Services (Somerset, NJ)
- …Specialist** will support the Quality department in the **planning, implementation, validation , and rollout** of computerized quality management systems (eQMS). The ... documenting **User Requirements Specifications (URS), Functional Specifications (FS),** and ** Validation Protocols (IQ/OQ/PQ)** . + Participate in and document… more
- Merck (Rahway, NJ)
- …Immunochemistry, Innovation, Laboratory Informatics, Liquid Chromatography (LC), Management Process , Matrix Management, Mentoring Staff, Method Validation ... a minimum of 8 years of experience in the pharmaceutical industry, MS in analytical chemistry/biochemistry or related field...standards of control strategy for residual HCPs and other process related impurities in biologics. + A strong team… more
- Ascendis Pharma (Princeton, NJ)
- …for the day-to-day management of contract operations activities across pharmaceutical pricing, contracting, and rebate agreements with payers, PBMs, GPOs, ... role will focus on contract lifecycle management, operations execution, and process improvement to ensure compliant and efficient contract implementation. Key… more
- Cytel (Trenton, NJ)
- …statistical support for CMC-related studies, including formulation development, stability studies, process validation , and analytical method validation . + ... to do the same. **Sponsor-dedicated:** Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at… more
- Actalent (East Windsor, NJ)
- …Development. + Develop and update analytical test reports/Certificate of Analysis, validation protocols (IQ/OQ/PQ), and stability study reports. + Prepare method ... validation protocol/reports, method transfer protocol/reports, technical documents, including change...with industry best practices, regulatory changes, and advancements in pharmaceutical quality control. Essential Skills + 4-5 years of… more
- Actalent (Somerset, NJ)
- …in HPLC, GC, Dissolution, and Particle Size Distribution. + Experience in pharmaceutical Method Development, Method Validation , and Stability Testing. Additional ... residual solvents testing, and particle size distribution of active pharmaceutical ingredients, excipients, and finished dosage forms. Responsibilities + Perform… more
- Actalent (East Windsor, NJ)
- …Control and Analytical Development. + Develop and update analytical test reports, validation protocols (IQ/OQ/PQ), and stability study reports. + Prepare method ... validation protocol/reports, method transfer protocol/reports, and technical documents including...with industry best practices, regulatory changes, and advancements in pharmaceutical quality control. Essential Skills + 4-5 years of… more
- Integra LifeSciences (Princeton, NJ)
- …URS documents, FRS and Configuration Specification documentation following Integra's Computer System Validation and Change control process to maintain the system ... analyzing business processes, evaluating user requirements and system specifications, process flows, group categories, terminology, states and activities, permissions,… more
- Merck (Rahway, NJ)
- …experience to develop safe and robust manufacturing processes through process characterization, technology transfer, validation , filing and supply ... **Required Experience and Skills:** Relevant work experience in chemical, pharmaceutical , large molecule, or vaccine process development, including… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …for technology transfer activities to new or existing CDMOs. + Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global ... robust and compliant manufacturing processes through effective technology transfer, validation , process monitoring, and lifecycle management. This individual… more