- Cytiva (Miami, FL)
- …managing sterility validation, providing training to teams, and participating in audits and investigations, all while ensuring compliance with industry standards and ... requirements.This position reports to the Contamination Control & Sterility Assurance Team Manager and is part of the Contamination Control & Sterility Assurance… more
- Honeywell (Baton Rouge, LA)
- …quality documents; prepares all corresponding documents and reports + Leads all external cGMP audits of vendors, including US and International cGMP , ... The Quality Assurance (QA) Manager oversees, implements, and maintains cGMP ...audits , as needed + Coordinates annual and ongoing cGMP training + Acts as a primary contact for… more
- Houston Methodist (Houston, TX)
- …daily tasks **GROWTH/INNOVATION ESSENTIAL FUNCTIONS** + Participates with the Quality Assurance Manager and/or cGMP Core Director in defining quality policies. + ... as necessary **SERVICE ESSENTIAL FUNCTIONS** + Participates in internal audits and external inspections by Regulatory Agencies and reports...Assists Quality Assurance Manager , cGMP Core Director and/or team members… more
- Sumitomo Pharma (Morrisville, NC)
- …We seek a dynamic, highly motivated, and experienced individual for the Manufacturing Manager , cGMP Manufacturing role. The Manufacturing Manager will ensure ... needed. + Prepare for and successfully participate in internal audits and FDA inspections. + Prioritizes the work of...preferred. + Experience at an FDA approved or late-stage cGMP manufacturing site + Experience in production batch record… more
- Fujifilm (College Station, TX)
- …**_Summary:_** Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking an **eQMS Manager ** to lead the configuration, implementation, analysis, and maintenance of ... Quality Management Systems (eQMS)** . This role ensures compliance with ** cGMP , and regulatory requirements** while optimizing eQMS functionality and efficiency. The… more
- Fujifilm (Morrisville, NC)
- **Position Overview** The Senior Manager , Quality Compliance is responsible for the day-to-day activities of the Pharmaceutical Quality Systems (PQS) team regarding ... Inspection Readiness, Site Internal Audits , and Quality Management Review (QMR). This role focuses...for you. From our Bioprocess Innovation Center to our cGMP -compliant manufacturing site, we thrive on collaboration, creativity, and… more
- Catalent Pharma Solutions (Harmans, MD)
- …and ensure compliance with all relevant quality standards, regulations, and guidelines (eg, cGMP , FDA, ISO). + Support internal audits , supplier audits , ... **Senior Manager , CAPA** **Summary:** _Catalent, Inc. is a leading...and life-saving treatments for patients annually._ _Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on… more
- Curia (Albuquerque, NM)
- Manager , Microbiology in Albuquerque, NM Build your future at Curia, where our work has the power to save lives Curia is a global contract development and ... matching contributions + Learning platform + And more! Summary The Microbiology Manager is responsible for overseeing the daily operations of the Microbiology… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …with a variety of dosage forms. * Working experience conducting and/or hosting cGMP audits . * Certification from the American Society for Quality (ASQ) ... include managing and conducting activities related to current Good Manufacturing Practice ( cGMP ) site audits , quality control and manufacturing (QCM) product… more
- ADM (Kennesaw, GA)
- …with the Quality Manager to lead all ISO 17025 and regulatory audits related to the laboratory operation + Submit performance improvement initiatives and drive ... **95334BR** **Job Title:** QC Lab Manager - Kennesaw, GA **Department/Function:** Operations: Manufacturing, Production, Maintenance, Utilities **Job Description:**… more
- DuPont (Hemlock, MI)
- …healthcare market quality requirements (including Current Good Manufacturing Practice [ cGMP ] standards). This person will provide leadership while maintaining ... quality certifications, quality-related aspects of supplier relationships, training, quality audits , and Corrective and Preventive Action [CAPA] initiatives. This… more
- PCI Pharma Services (Philadelphia, PA)
- …network to pioneer and shape the future of PCI. The Sr. Operations Manager is responsible for the safety, quality, and operational excellence for Advanced Drug ... along with all federal, state and local regulations, including OSHA, FDA, cGMP standards and employment law + Demonstrate substantial knowledge of the pharmaceutical… more
- Novo Nordisk (Bloomington, IN)
- …disposition. Quality & Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support ... contact for key customers + Manages QA resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records,… more
- Novo Nordisk (Bloomington, IN)
- …in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include manual, semi-automated and automated inspection, ... in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank… more
- Amgen (Thousand Oaks, CA)
- …Join us and transform the lives of patients while transforming your career. Maintenance Manager **What you will do** Let's do this! Let's change the world! This role ... within the Manufacturing Clinical Supply (MCS) organization at Amgen. The Maintenance Manager - will be responsible for leading maintenance teams, ensuring reliable… more
- Amgen (Holly Springs, NC)
- …Join us and transform the lives of patients while transforming your career. **Senior QA Manager ** **What you will do** Let's do this! Let's change the world! In this ... properly trained and qualified to perform their duties in accordance with cGMP and regulatory requirements. + Oversee workload distribution, resource planning, and… more
- Fujifilm (College Station, TX)
- …and excipients, represents the QC Raw Materials team during regulatory and customer audits . The Manager models leadership competencies and aids in the ... **Position Overview** The **Raw Materials QC Manager ** is accountable for GMP compliant laboratory operations...team and laboratory maintains inspection readiness for customer visits, audits and regulatory inspections following cGMP guidelines… more
- Biomat USA, Inc. (Channelview, TX)
- …in more than 110 countries and regions. **Plasma Center Quality Systems Manager (QSM)** **PRIMARY RESPONSIBILITIES** : + Evaluates processes, develops action plans, ... staff competency in their assigned job duties. Maintains and audits training records and files. + Collaborates with Center... training records and files. + Collaborates with Center Manager to ensure the donor center operates in a… more
- BeOne Medicines (Pennington, NJ)
- …compliance and achieving business success. Work to support both internal GMP audits and Health Authority audits . Supports QA Manufacturing related tasks ... shop floor and batch systems to ensure compliance with FDA/EU regulations, covering cGMP for commercial medicinal products and clinical material for human use. +… more
- Vantage Specialty Chemicals (Gurnee, IL)
- …site maintains its quality registrations eg ISO 9000; passes all regulatory and customer audits ; and ensures the site meets cGMP and IPEC requirements and good ... **Position Summary** The purpose of the Quality Manager is to lead and maintain the site...and foster collaboration. + In-depth knowledge of ISO 9000, cGMP , IPEC, COSMOS, RSPO and relevant certification standards. +… more
