- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …recommending and implementing innovations where appropriate + Ensure compliance with cGMP regulations and other relevant quality standards + Represent the MSAT ... scale-up, and technology transfer of biologics products + Strong knowledge of cGMP regulations and ICH guidelines relevant to biologics manufacturing + Experience… more
- Sanofi Group (Ridgefield, NJ)
- …as required + Complete and provide accurate documentation, as required in cGMP operations Reviews and closes all paper and electronic preventive and corrective ... P&IDs + Experience working for a metrology organization in a cGMP Biotech/Pharmaceutical manufacturing environment + Proficient computer skills utilizing MS Office… more
- Catalent Pharma Solutions (Bridgewater, NJ)
- …knowledge as a subject matter expert and resource. Demonstrated understanding cGMP requirements related to change and change management. + Demonstrates the ... well with-in a cross-functional team atmosphere. + Strong knowledge of cGMP and QbD regulations/guidance pertaining to Pharmaceutical industry. Fully competent in… more
- Integra LifeSciences (Princeton, NJ)
- …risk management files. + Ensure that all projects are in compliance with cGMP , cGLP, QSR (including Design Controls), ISO or other applicable requirements. **DESIRED ... using eQMS software solutions. + Knowledge of current Good Manufacturing Practices ( cGMP ) and other applicable standards. + Experience using analytical tools to… more
- Integra LifeSciences (Princeton, NJ)
- …management tools. + Ensure that all projects are in compliance with cGMP , cGLP, QSR (including Design Controls), ISO or other applicable requirements. **DESIRED ... using eQMS software solutions. + Knowledge of current Good Manufacturing Practices ( cGMP ) and other applicable standards. + Experience using analytical tools to… more
- Bristol Myers Squibb (Summit, NJ)
- …to ensure compliance with applicable local, state, federal regulations (eg, OSHA, EPA, ISO, cGMP ). + Serve as the site lead for EHS data management systems, ensuring ... accuracy and timely reporting of key metrics and performance indicators. + Analyze S&OH performance data to identify trends, create dashboards, and present actionable insights to leadership. + Develop and deliver clear and impactful PowerPoint presentations… more
- Bristol Myers Squibb (Summit, NJ)
- …of Cell Therapy products according to Current Good Manufacturing Practices ( cGMP 's) following the current, approved Standard Operating Procedures (SOPs) and Work ... Instructions (WIs). + Responsible to own, review, author, or approve SOP, WI, master batch records. + Takes personal responsibility to work safely and to ensure their managers and WCT members do the same. + Performs regular safety Gemba walks, knows the… more
- Bristol Myers Squibb (Summit, NJ)
- …Syncade & Recipes testing phases (IQ, System Testing, Recipe UAT). + Familiarity with cGMP , GAMP, SDLC, 21 CFR Part 11, and Good Documentation Practices (GDP). + ... Demonstrated ability to independently lead system validation efforts across multiple stakeholder groups. **Basic Qualifications** + Bachelor's degree in Computer Science, Information Systems, or a related engineering discipline. + Minimum 5 years of experience… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …service providers. + Working knowledge of current Good Manufacturing Practice ( cGMP ) regulations. + Strong project management, leadership, problem solving, and ... organization skills. + High level of emotional intelligence. + Exceptional leadership and team development skills. + Excellent communication and interpersonal skills. + Ability to work collaboratively with cross-functional teams. + Strategic thinking and… more
- Actalent (Fairfield, NJ)
- …product flavor and quality. + Working knowledge of basic lab techniques and cGMP standards. + Experience in product and formula development and evaluation. + Strong ... knowledge of ingredient costing and technology. + Ability to read and interpret safety rules, operating and maintenance work instructions, procedure manuals, and SDS sheets. + Effective oral and written communication skills. + Proficiency in using simple… more