- Actalent (Princeton, NJ)
- …Essential Skills 3+ years of cell therapy experience. 3-5 years of GMP manufacturing experience. Quality Assurance oversight for manufacturing floors. Experience ... Proficient in investigation tools like Fishbone diagrams, 5 Whys, and FMEA. Ability to lead and close complex quality investigations. Willingness to work in ISO… more
- Katalyst HealthCares and Life Sciences (Rahway, NJ)
- …strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. The Associate Principal Scientist is also ... as needed. Critically evaluate health authority questions with the respective CORA and lead the answer team of cross-functional SMEs to compile the responses in… more
- Bausch Health (Bridgewater, NJ)
- …support in reviewing and approving CAPA (Corrective and Preventive Actions), product quality complaints. Support and lead Escalated Events, Technical Review ... New Jersey, USA Job Requisition ID: 13640 Join our global diversified pharmaceutical company enriching lives through our relentless...data collection for quality metrics, scorecards, and quality review board meetings. Lead internal audits,… more
- Rocket Pharmaceuticals (Cranbury, NJ)
- …development, scheduling, and delivery of the designed training courses. 9. Support Quality Culture enhancement efforts, lead the training sessions by delivering ... training strategies and requirements. This position reports to the Director - Quality Assurance QMS. Responsibilities 1. Manage training program in line with… more
- BeiGene, Inc. (Pennington, NJ)
- …Chain, Technical and Operational departments frequently. Interacts with BeiGene Global Quality . Supervisory Responsibilities: This position includes managing ... may include some travel. Essential Functions of the job : Within the Quality Assurance organization, develop and implement Compliance programs for the Hopewell, NJ… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Quality Lead , GMP , GDP Audit and Inspection - Pipeline Launch **Location:** Framingham, MA or Morristown, NJ **About the Job** We ... in Sanofi. + **Scope:** Manufacturing & Supply, Research & Development, Countries, Digital, Global Quality organizations in Sanofi. And third parties outside of… more
- Berry Global (Monroe Township, NJ)
- …planning, use of inspection devices, software, and inspection equipment. 3.5 Use quality related software and hardware to inspect/monitor product quality through ... drawing specifications and tolerances. 3.9 Prepare, process and maintain quality records as prescribed by QA procedures or work...clean and orderly work area. 3.16 Follow all company GMP and safety policies 3.17 Report accidents and or… more
- Berry Global (Monroe Township, NJ)
- …by First Article and In-Process Inspection procedures and assigned by the Lead Inspector. Follow all work instruction related to in process inspection. 3.2 ... Conduct daily dimension as required by department procedures, or Lead Inspector. 3.3 Clearly document Inspection results on Inspection sheets maintaining GMP … more
- Catalent Pharma Solutions (Somerset, NJ)
- **Job Title: Global Director, Continuous Improvement** **Location: Bridgewater, NJ** **Position Summary** The focus of this role will be identifying and implementing ... and late-stage clinical products efficiently, timely, and with high quality . Scope of the role covers the entire product...delivery of the cost transformation across the company. The Global Director Continuous Improvement will be part of the… more
- Bristol Myers Squibb (Summit, NJ)
- …better place than here at BMS with our Cell Therapy team. The ** Lead Project Engineer, Equipment Commissioning and Qualification (ECQ)** Delivery, plays a key role ... to meet business needs in accordance with required schedules or dates. + Lead and oversee contract project teams to ensure timely execution and adherence to… more
- Bristol Myers Squibb (Summit, NJ)
- …as the Global Technical SME for Drug Product and Vector Validation. The lead will develop global technical standards for cell therapy validation and deploy ... providing SME assessment for proposed process life-cycle changes. The lead will serve as the Global Point...global cell therapy validation technical standards via the quality system. + Promote innovative and efficient approaches to… more
- Actalent (Princeton, NJ)
- …Essential Skills + 3+ years of cell therapy experience. + 3-5 years of GMP manufacturing experience. + Quality Assurance oversight for manufacturing floors. + ... deviation identification. + Ensure all manufacturing activities comply with GMP and regulatory requirements. + Review and approve ...Fishbone diagrams, 5 Whys, and FMEA. + Ability to lead and close complex quality investigations. +… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …The Vice President of Central Quality Operations will lead and influence Quality strategy for Gilead Global Quality Management System (QMS) and the ... significant impact across many areas as the QMS and Global Market GMP /GDP activities are core to...of findings to key stakeholders, essentially acting as the lead quality expert in ensuring the report… more
- Lilly (Branchburg, NJ)
- …to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work ... we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards… more
- Promotion In Motion (Somerset, NJ)
- Forklift Lead - 3rd Shift Job Details Job Location Somerset - Somerset, NJ Position Type Full Time Education Level High School Travel Percentage None Job Shift 3rd ... your area of expertise. We are looking for Forklift Lead interested in a career with a top ranked...counting and monitoring inventory + Report food safety and quality issues to Plant management and SQFP + Follow… more
- Bristol Myers Squibb (Summit, NJ)
- …GDPs. + Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements. + Works in a team-based, cross-functional ... lives. Read more: careers.bms.com/working-with-us . **Job Title** : Manufacturing Team Lead , Liso-cel CAR-T **Location** : US-NJ-Summit West, S12 **Department** :… more
- Sanofi Group (Morristown, NJ)
- …and high- quality responses and support the development and promotion of Global Quality Documentation. + Supports the preparation, execution and closure of ... purposes, and ensuring accurate reporting to Operations Management and Global Quality . . **Core member of critical.... . **Core member of critical governance** + Sanofi's GMP GDP Quality Council to facilitate sharing… more
- dsm-firmenich (Somerset, NJ)
- **Sr. Team Lead 2nd Shift, Production, PE** **Somerset, NJ, US** This position will lead and coordinate and manage the 3rd shift Production Team, providing ... implementing process improvement initiatives. + Conduct daily audits of Quality Risk Assessments, proactively addressing and preventing non-conformances and utilize… more
- Bristol Myers Squibb (Summit, NJ)
- …place than here at BMS with our Cell Therapy team. The ** Lead Computer System Validation (CSV) Engineer** supports the successful implementation of manufacturing ... while promoting a positive learning, team environment. + Author quality procedures and training documents. + Deliver training on...office environment. Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats… more
- Kelly Services (Skillman, NJ)
- …and biotechnology industry, specializing in ** Quality Control (QC), Quality Systems, Analytical Method Validation** , and ** Global Specification ... authoring and reviewing documentation in systems such as **TrackWise** and **Veeva Vault Quality Docs** . + Lead the **digital transformation of QC systems**… more
