- Astrix Technology (New Brunswick, NJ)
- …& Responsibilities** + Perform downstream processing at various scales in a cGMP environment, including column packing, process troubleshooting, and data analysis. + ... Provide technical guidance in the execution and development of purification processes. + Utilize systems to collect and analyze operational data and make real-time adjustments to products, instruments, or equipment. + Ensure timely execution of engineering and… more
- Merck (Rahway, NJ)
- …global medical device and healthcare regulations, including FDA combination products cGMP , Quality System Regulation, FDA Human Factors guidance, ISO 14971, 11608 ... and 11040, EN 62366, Council Directive 93/42/EEC, etc. + Additionally possess extensive knowledge in traditional worldwide pharmaceutical regulations including but not limited to 21CFR210, 211, 600-680, ICH Q8/9/10, Directive 2001/83/EC and comparable… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …standard protocols, maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs. + -Utilize techniques of Spectrophotometry, HPLC, ... GC, dissolution, and wet chemistry tests in accordance with the USP. + Interpret and communicate analytical results. + Contribute to technical problem solving and troubleshooting as needed. + Contribute towards optimizing laboratory operations to increase… more
- Astrix Technology (Trenton, NJ)
- …feasibility studies of product/process + Participate in process validation and cGMP implementation. + Test process changes, troubleshoot issues, and offer plant ... support. **Education & Experience** + BS or MS in Chemical, Materials, or similar + 2+ years of relevant experience. Pay: $38-42/hr This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who… more
- Astrix Technology (New Brunswick, NJ)
- …experience in QC or equivalent roles. + Comprehensive knowledge of cGMP in pharmaceutical/biopharmaceutical settings. + Experience in inspection readiness for ... audits. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic… more
- Mallinckrodt Pharmaceuticals (Somerset, NJ)
- …DOT regulations + Must have a thorough knowledge of applicable Federal Regulations ( cGMP , DOT, IATA, OSHA) + Must have proficient computer skills, ideally with ... experience using SAP, Oracle or equivalent ERP system, Warehouse Management System. + Overnight travel required (can be between 2-4 nights/wk). Competencies: + Navigate and perform transactions in SAP accurately + Maintain a clean driver record + Detail… more
- Merck (Rahway, NJ)
- …to all stages and aspects of development (pre-clinical, clinical, and commercial) and cGMP industrial background. + Experience with design of IV and SC drug products ... including drug-device combination products for biologics + Experience with process design and/or scale-up in the clinical or commercial space, including process flow diagrams & engineering drawings + Process development and technology transfer experience… more
- Integra LifeSciences (Plainsboro, NJ)
- …skills. * Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP preferred. * Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) ... preferred. * Ability to define problems, collect data, establish facts and draw valid conclusions. * Ability to work effectively in a cross functional environment. * Ability to integrate quality objectives across multiple functions. * Attention to detail and… more
- Astrix Technology (Middlesex, NJ)
- …**Essential Duties & Responsibilities:** + Perform downstream processing in a cGMP environment, including tasks such as column packing, troubleshooting processes, ... and analyzing data. + Provide technical support in the development and execution of purification processes to ensure consistent, high-quality results. + Utilize operational systems to monitor and analyze data, making real-time adjustments to products,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …drugs and other co-meds for clinical studies . Mature knowledge of the FDA, cGMP , GCP standards and regulatory guidance documents such as CFR, Annex 13. . Possess ... strong clinical supplies management experience/ knowledge in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations . Possesses… more