- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and effective resolution and robust compliance. **Key Responsibilities** + Global Process Ownership: Lead the design, implementation, and continuous improvement of ... electronic quality systems (eg, TrackWise), including configuration, training, and validation . + Cross-Functional Collaboration: Partner with regional quality leaders,… more
- BeOne Medicines (Pennington, NJ)
- …Manager requires rich technical experience in construction project management for pharmaceutical production facility and ability to manage projects and ensure ... highly desirable. + Special knowledge requirements include biopharmaceutical and pharmaceutical processes and facility design approaches, plus a solid understanding… more
- Bristol Myers Squibb (Madison, NJ)
- …working directly with QC, QA, Manufacturing, Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs, and ... Development Organizations on the resolution of issues associated with process /manufacturing, control strategy, analytical methods, specifications, reference standards, stability,… more
- Insight Global (Parsippany, NJ)
- …Author will be responsible for authoring recipes within Rockwell PharmaSuite, validation , gathering business requirements, identifying process improvements, and ... Insight Global is looking for an EBR Recipe Author to join the engineering organization of a pharmaceutical company located in Parsippany, New Jersey. The Recipe… more
- Kelly Services (Princeton, NJ)
- …daily QC Chemistry lab operations, ensuring timely and accurate testing for in- process materials, drug substance (DS), drug product (DP), and stability samples. ... CAPAs. + Manage and coordinate method transfers and method validation /verification activities, including strategy development and protocol/report approvals. **Required… more
- Adecco US, Inc. (Ridgefield, NJ)
- …and Saline production, intermediate bulk manufacturing, filling, inspection, and packaging process for medical device products along with pharmaceutical based ... production space. Prepare equipment, filters, etc. required for production. Assists in process and system validation activities as required. Performs product… more
- Merck (Rahway, NJ)
- …environment. In this role, you will be supporting product formulation and process development and commercialization for our Company's new products utilizing various ... Responsibilities include, but are not limited to: + Analytical testing for process and product characterization + Analytical method development and validation … more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …corporate quality objectives. The position drives governance, technology enablement, and process optimization for training systems and programs across GxP and ... experience and compliance tracking. + Ensure data integrity and system validation in accordance with GxP requirements. **Operational Excellence** + Lead global… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …support OPDC R&D products; including LIMS data, method development & validation , method transfers and testing (release, stability). + Maintains KPIs/quality metrics ... related Science. + Four years of combined experience in pharmaceutical /medical device industry as a manager in Manufacturing, QA...Thorough understanding of GMP requirements and the Drug Development process . + Knowledge of FDA 21 CFR Parts 210… more
- Actalent (Cherry Hill, NJ)
- …documents. These include Standard Operating Procedures (SOPs), Change Controls, Validation protocols, General Test Requirements (GTRs), Engineering Drawings, and ... environment. Responsibilities + Review and approve SOPs, Change Controls, and Validation protocols. + Evaluate and approve General Test Requirements (GTRs). +… more