- Allogene (Newark, CA)
- …documentation, monitoring methods performance and reporting any deviation or discrepancy to manager . This is a daily on-site position in Newark, CA. Responsibilities ... limited to: * Performs QC analytical testing to support the method validation activities, release and stability of intermediates, drug substance and final products… more
- Merck (Rahway, NJ)
- …and/or approve GMP documents. + Ensure all API are manufactured in compliance with cGMP and regulatory filings. + Perform independent quality review and approval ... Description** **Job Description** The Rahway based **Senior Specialist, Global Development Quality Operations - API** , is responsible for independent review and… more
- Novo Nordisk (Bloomington, IN)
- …Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site ... Team Novo Nordisk and help us make what matters. Relationships Reports to Manager . Essential Functions + Supplier Management + Provides support for the introduction… more
- Medtronic (Minneapolis, MN)
- …understanding of designs, documentation of compliance to requirements and timely, high- quality product launches that satisfy patient needs and reduce customer ... You will have primary focus and responsibility for the validation of design verification test methods for complex electro-mechanical...Familiarity with these regulations: FDA 21 CFR Part 820 cGMP , ISO 13485, ISO 10012, and ISO 17025. +… more
- University of Rochester (Rochester, NY)
- …GENERAL SUMMARY Apply their extensive current Good Manufacturing Practices ( cGMP ) experiences along with strong critical thinking skills to handle ... responsibilities of a more complex nature within the Quality Assurance function of Clinical Materials Services Unit (CMSU). **ESSENTIAL FUNCTIONS** Quality … more
- Curia (Burlington, MA)
- … quality system requirements * Work with Engineering, Materials Management, Quality Assurance and Validation to complete assignments, and ensure ongoing ... needed to execute a dynamic production schedule within the clean room cGMP facility. The Supervisor will work with cross-functional departments to complete… more
- Novo Nordisk (Bloomington, IN)
- …systems + Collaborate significantly with cross functional groups including Validation , Quality Control, Manufacturing, Process Development, and Facilities ... our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. As a part of Novo… more
- West Pharmaceutical Services (Walker, MI)
- …tooling to new and existing products to ensure safety, maximum yields, quality , cost effectiveness and throughput of our processes. **Essential Duties and ... process qualifications as required. + Read and understand the execution of validation documentation protocols and summary reports. + Assist with the implementation… more
- Bristol Myers Squibb (Indianapolis, IN)
- …in a cGMP /FDA regulated facility required + Strong experience with cGMP regulations, ICH guidelines, quality systems, and safety guidelines + Experience ... for a Scientist I for the QC Microbiology department. Reporting to the Manager of Microbiology, this individual will help support the microbial contamination control… more
- System One (Harvard, MA)
- …understanding of Quality Systems Regulatory expectations + Reviews and approves Quality , Quality Control, Validation and Automation related documents + ... Manager Sometimes will interact with departments listed below: Quality Control Manufacturing Operations Manufacturing Engineering Manufacturing Science and… more