- Cipla (Fall River, MA)
- …as FDA 21 CFR Part 11, ICH, and ISO. This role supports the Quality Management System (QMS) by maintaining accurate, secure, and accessible documentation ... Job Title : QA Document Control Associate FLSA Classification : Full-Time, Professional Work...role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The position reports to the QA QMS… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team setting with quality counterparts that include Manufacturing Operations, Quality Control , and Operations Technical Support.RequirementsA minimum of a ... Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).Operational experience with electronic quality systems.Familiarity with core Quality Management System… more
- Merck & Co. (Rahway, NJ)
- …or related industryExperience in one or more functional areas such as quality control , quality assurance, analytical laboratories, manufacturing, production ... Manufacturing Practices (GMP), Immunochemistry, Interpersonal Relationships, Manufacturing Processes, Manufacturing Quality Control , Microbiology, Molecular Microbiology, Physiology, Process… more
- Repligen (Rancho Dominguez, CA)
- …for appropriate quality requirements.Preparing appropriate documentation for critical quality control points throughout the manufacturing processes. Ensures ... processes.Performing FMEA analysis, RCA, Gauge R&R studies, statistical evaluation, and process control activities to resolve and prevent quality and reliability… more
- Twist BioScience (South San Francisco, CA)
- … and safety of our genomic products and services by implementing and maintaining a quality management system (QMS) that complies with ISO 13485 and ISO 14971. ... prevent recurrence of non-conformities.Provide technical support to the R&D team on quality matters, including design control , process validation, and change … more
- Merck & Co. (Rahway, NJ)
- …architecture awareness and experience working with software engineering and control systems teams. Excellent stakeholder management , executive communication ... and operations to deliver capabilities that materially improve throughput, quality , flexibility and cost-to-serve for highly customized manufacturing requirements.… more
- Insmed Incorporated (NJ)
- … management experience.Proven expertise in root cause analysis, investigations, change control , and Quality risk management .Direct experience with ... cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive Quality input into development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …core knowledge and applied critical thinking skills in Technology Management of monoclonal antibodies to develop and commercialize Daiichi Sankyo's ADCs pipeline ... and external manufacturing network and Potential involvement with all phases of project management Work with operations and quality groups to maintain products… more
- Formation Bio (New York, NY)
- …vendor relationships and governance, holding external partners to high standards of quality , cost control , and on-time deliverables. Serve as the Operations ... faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the clinical… more
- Insmed Incorporated (NJ)
- …seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role will manage ... while maintaining operational excellence. The Executive Director, Cybersecurity & Risk Management plays a critical leadership role in safeguarding that mission.… more
- Merck & Co. (Rahway, NJ)
- … management , design verification, automation/process development, design validation, and control strategy. Knowledge of US and global medical device and ... and development; manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to ... standardize, optimize, and innovate signal detection and management processes across the global safety organization. The incumbent...maintenance of signal tool and support tasks of change control , training material update, and end user support or… more
- Repligen (Waltham, MA)
- … Management , System Operations, and IT Governance.Conduct IT application control reviews for key systems (eg, SAP, Tagetik, Workday, ServiceNow).Provide guidance ... IT, Financial Reporting, and external auditors to strengthen Repligen's control environment.ResponsibilitiesKey ResponsibilitiesLead the planning, execution, and documentation of… more
- Merck & Co. (Durham, NC)
- …to resolve process/equipment issues, minimize downtime, and ensure product quality .Key ResponsibilitiesEmployee Development / People Management :Hire, develop, ... teams.Line clearance LOTO and permit writing for maintenance activities, Safety Management Information Systems (SMIS). Knowledge of electrical maintenance and… more
- Master Builders Solutions (Kingman, KS)
- …other high-performance industrial products. With a proud tradition of innovation and quality , Fabpro now operates as a subsidiary of Master Builders Solutions. ... and other measuring instruments. + Adjusts functional parts of devices and control instruments by using hand tools, levels, plumb bobs, and straightedges. +… more
- Merck & Co. (Durham, NC)
- …The site includes clean utilities, facilities equipment, manufacturing production equipment, quality labs and a warehouse. The candidate will support the ... validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces an inclusive team… more
- Cipla (Reid, WI)
- …Provides data to support management evaluation of performance trends. Owns quality records (change control , CAPA's, deviations) and delivers to established ... and strategies to customers and regulatory auditors. Performs weekly quality reviews of Master Control database by...plus. Experience in Inhalation products (MDI) is a plus. Knowledge and handling of deviation, CAPA, change control… more
- Cipla (Fall River, MA)
- …the validation programs and strategies to customers and regulatory auditors. Performs weekly quality reviews of Master Control database by assuring new documents ... and applications is a plus. Experience in Inhalation products (MDI) is a plus. Knowledge and handling of deviation, CAPA, change control , FMECA and training. … more
- Cipla (Fall River, MA)
- …such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing ... and qualification documents. Provide daily/weekly updates to shop floor and management regarding the quality highlights/concerns. Create lessons learned for… more
- Merck & Co. (Durham, NC)
- …Interpersonal Relationships, Lean Six Sigma Tools, Lockout Tagout, Manufacturing Quality Control , Pharmaceutical Microbiology, Plant Maintenance, Process ... and major), with responsibility to interface with Operations, Maintenance, Automation, and Quality approvers.- As part of the deviation management role, present… more
