- Merck & Co. (Durham, NC)
- …regulatory inspectors-Required Skills: Adaptability, Adaptability, Biodesign, Change Control Management, Chemical Engineering , Collaborative Communications, ... & Component SuppliersDevelop effective data analytics methodologies, including statistical process control , deepening process understandingAuthor, review,… more
- Merck & Co. (Durham, NC)
- …Experiments, Mammalian Cell Culture, Multi-Management, Personal Initiative, Pilot Plant Operations, Process Automations, Process Engineering , Process ... positions to partner with Manufacturing Operations, Quality Operations and Process Automation. GVTE provides technical engineering and manufacturing support… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Sr. Tech, Engineering is a member of the Engineering team providing technical support to ... validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces an inclusive team… more
- Merck & Co. (Rahway, NJ)
- …knowledge in QbDRequired Skills: Applied Engineering , Applied Engineering , Capital Management, Change Management, Chemical Process Development, ... Process Improvements, Product Commercialization, Product Lifecycle, Product Management, Regulatory Requirements, Results-Oriented, Social Collaboration, Stakeholder Engagement, Stakeholder Negotiations… more
- Merck & Co. (Rahway, NJ)
- …expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and design control and ... experience with deep working knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes.… more
- Twist BioScience (South San Francisco, CA)
- …Assurance, Regulatory Affairs, Supplier Quality, Supply Chain, Quality Control , Production, Process Development, Product Development, Software Development, ... and Technical Documents including, but not limited to: SOPs, Design Control Documentation (Design and Development Plan, Customer Requirements, Product Requirements,… more
- AUROBINDO (Durham, NC)
- …management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under ... a team player able to effectively communicate with QA Supervisor, IPQA, Quality Control , Production, Warehouse, Engineering and Supply Chain to meet finished… more
- Merck & Co. (Rahway, NJ)
- … control and risk management processes Identify and eliminate process inefficiencies using operational excellence tools Develop training materials to foster ... regulations. Leverage data analytics and key performance indicators to monitor process performance. Support internal audits, regulatory inspections, and… more
- Novo Nordisk Inc. (Durham, NC)
- … regulatory requirements through the following activities: People Focus, Process Focus, Equipment Focus & Standards "Gatekeeper". Relationships Reports to ... Manager, Technical Support. Essential Functions Coach & mentor peers, Engineering personnel & Process Maintenance Technicians. Support technical development of … more
- Merck & Co. (Rahway, NJ)
- …and spray drying.Understanding of microbial strain development and genetic engineering techniques to support process optimization.PRDRequired Skills: ... Mentorship, Microbial Fermentation, Process Analytical Technology (PAT), Process Scale Up, Regulatory Compliance, Scientific Innovation, Strategic… more
- Merck & Co. (Rahway, NJ)
- … Automation, Process Optimization, Product Formulation, Project Management, Quality Control Management, Regulatory Compliance, Regulatory Issues, Safety ... Estimation and Planning, General Safety, Manufacturing Quality Control , Mechanical Troubleshooting, Pharmaceutical Process Development, Process Control… more
- Merck & Co. (Durham, NC)
- … Process , Medical Devices, Molecular Microbiology, Quality Auditing, Quality Control Documentation, Quality Control Management, Quality Management Systems ... agent related to culture and audit program performance Lead change and process improvement initiatives related to Auditing, Inspections, CAPA, and other compliance… more
- Merck & Co. (Rahway, NJ)
- …Sciences, Process Design, Process Hazard Analysis (PHA), Process Optimization, Proper Documentation, Regulatory Compliance, Regulatory Requirements ... Job Description Job Description: The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug… more
- ValSource, Inc. (Rahway, NJ)
- …validation protocols and documents for a variety of utilities, facilities, and process equipment used in the FDA regulated pharmaceutical and biotech manufacturing ... client sites, ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves extensive travel to various… more
- Aequor (West Greenwich, RI)
- …(PQA) professional, providing on-the-floor quality oversight for Facilities and Engineering (F&E), Process Development, Incoming Quality Assurance (IQA), ... within bulk drug substance operations adhere to cGMP and other regulatory requirements. Key Responsibilities: Provide quality oversight for F&E, IQA Warehouse… more
- Merck & Co. (Rahway, NJ)
- …Compliance Packaging, Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Management ... Process , Manufacturing Scale-Up, Mentorship, Packaging Engineering , Process Optimization, Risk Management, Root Cause Analysis (RCA), Social Collaboration,… more
- Cipla (Fall River, MA)
- …and regulatory auditors. Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate protocols. ... Track and manage periodic review. Develop strategies and documents for cleaning and process validation of API equipment and products in compliance with site SOPs and… more
- Cipla (Fall River, MA)
- …and regulatory auditors. Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate protocols. ... review of approved procedures. Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and… more
- Syner-G BioPharma Group (Boston, MA)
- …facility’s emergency response procedures.Work closely with other departments, such as engineering , manufacturing, quality control , and research and development, ... strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submissions Understand manufacturing changes to ensure compliance with appropriate change control systems/ process and support regulatory filing strategy ... with a concentration in Chemical, Biochemical, Biomedical or other related Engineering disciplines, Regulatory or pharmaceutical science, or other related… more
