- System One (Park Ridge, NJ)
- …of high- quality outcomes + Communicate updates and findings to senior leadership clearly and effectively + Cross-Functional Collaboration + Partner with product ... an innovative and trusted partner in infection prevention and control . + You will lead the strategic direction of...development, packaging, operations, quality , and regulatory affairs to integrate microbiological and sterilization… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …including resource allocation, procurement, scheduling, budgeting, risk management, communication, quality assurance, and scope control . + .Direct ... project or process-related issues to meet key objectives such as quality , customer satisfaction, productivity, and cost efficiency. + .Leverage project management… more
- PCI Pharma Services (Philadelphia, PA)
- …Philadelphia, PA 19114 Department: Operations Shift: 1st Shift Reporting To: Operations, Senior Director **JOB SUMMARY:** Are you a visionary leader with a passion ... to enhance their skills and performance. + Monitor and control maintenance budgets, ensuring cost-effective use of resources, and...controls, robots, and machines. + Adhere to all PCI, cGMP , and GCP policies, procedures, and rules. + Perform… more
- Amgen (Holly Springs, NC)
- …technologies. + Experience or solid understanding of current Good Manufacturing Practices ( cGMP ), 21CFR Part 11 regulations, change control and validation. + ... but not limited to Process Modeling and Simulation, Data Driven Process Control , Internet of Things, Automated Warehouse solutions, and Automated Guided Vehicles.… more
- Fujifilm (Holly Springs, NC)
- …of Engineering and/or Maintenance experience * Experience with Engineering drawings and Quality Systems (eg, deviation management, change control , corrective and ... **Position Overview** The Senior Reliability Engineer is responsible for life cycle...orders in the Computerized Maintenance Management System (CMMS) and Quality Event Metrics (QEM) to identify trends and areas… more
- ThermoFisher Scientific (Bedford, MA)
- …with manufacturing on various chromatography resin production goals: including efficiency, quality control , specification targets. + Communicate clearly and ... global and US-based projects, maintaining a strong focus on safety and quality . + Ensure successful execution of raw material second-sourcing and process validation… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …and industry best practices related to adventitious virus testing and viral safety control + Practical experience of cGMP manufacturing operations and fluency of ... partnering closely with Research, Analytics, CMC, Regulatory, Commercial Manufacturing, Quality , and external partners. In addition, this individual will drive… more
- PCI Pharma Services (Madison, WI)
- …critical utilities, process and laboratory instrumentation are maintained in a state of control and full compliance with cGMP and GDP requirements. The incumbent ... guidance, training, feedback, coaching, mentoring, and discipline as directed by senior management and/or company policy. **Work Environment:** The work environment… more
- Actalent (Grand Rapids, MI)
- Job Title: Regulatory Affairs SpecialistJob Description The Senior Regulatory Affairs Specialist/Compliance Specialist/QA Specialist oversees regulatory affairs ... approved commercial products for Cares Act Reporting. + Facilitate client quality agreements, ensuring alignment with regulatory requirements. + Submit annual GDUFA… more
- Actalent (Bartlett, IL)
- …support to microbiology lab technicians, ensuring timely product release through rigorous quality control analyses. You will perform microbiology QC analyses ... Title: Microbiologist Job Description We are seeking an experienced Senior Microbiologist to join our laboratory team. In this...team. Additional Skills & Qualifications + Experience with GMP, cGMP , GLP, GDP. + Experience in pharma, OTC, personal… more