- BioFire Diagnostics, LLC. (Lombard, IL)
- The GMP Training Specialist plays a pivotal role in developing, delivering, and maintaining effective training programs that ensure regulatory compliance ... or GED: + Minimum of 5 years of experience in training development, preferably in a GMP /GxP environment. + Relevant certifications (eg, CPTM, CQIA, CID) are… more
- Catalent Pharma Solutions (Chelsea, MA)
- ** GMP Training Specialist - QA** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical ... DPI in North America. Catalent Pharma Solutions is hiring a Quality Systems Specialist ( Training ) who is responsible for administrative management and oversight… more
- Regeneron Pharmaceuticals (Troy, NY)
- …quality and ensuring DG principles are embedded in the site culture. As a Senior GMP Data Governance & Engagement Specialist , a typical day might include the ... ensuring compliance with DG policies; crafting and delivering relevant training ; and monitoring DG practices. The role is pivotal...& Programs) Team to craft & deliver continuous DG Training in line with current and evolving required DG… more
- ThermoFisher Scientific (Middleton, WI)
- …Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards **Job Description** Scientist - Cell and Gene ... Therapy Specialist II, Clinical Lab Scientist Middleton, Wisconsin, United States...Ensures QA findings are addressed appropriately. + Aids and training to other team members. + Problem solving, either… more
- Catalent Pharma Solutions (Harmans, MD)
- **Manufacturing Specialist - Training ** **Summary:** _Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the ... including AAV and other viral vector-based therapies and vaccines._ The **Manufacturing Specialist - Training ** supports the day-to-day operations of the… more
- Integra LifeSciences (Boston, MA)
- …and competencies of employees in a medical device-regulated environment. The Senior Training Specialist will assess training needs, develop curriculum, ... performance and align with Integra's core values. The Senior Training Specialist will collaborate with various stakeholders...with subject matter experts, that adhere to GDP and GMP standards. + Identifying training needs by… more
- Boehringer Ingelheim (Fremont, CA)
- …leader of non-routine, new initiatives with local cross functional impact. Establishes training curricula and train others as a SME. Establishes timelines, sets ... strategy for site wide QC projects. + Maintains own training within compliance and trains other technicians and associates...years of work experience in analytical testing in a GMP regulated industry or equivalent; Or + Masters degree… more
- Hovione (East Windsor, NJ)
- …plans (and related reports) for Quality Assurance: periodic revision of procedures, GMP training , internal audits + Publish Quality Agreements applicable to ... of product documentation and operations throughout the products lifecycle. Provides GMP documentation services in support of new product introduction and existing… more
- Integra LifeSciences (Plainsboro, NJ)
- …possible and making headway to help improve outcomes. **SUMMARY DESCRIPTION** The Senior Training Specialist , QA will create and conduct training programs ... of employees in a medical device-regulated environment. The Senior Training Specialist will assess training ...with subject matter experts, that adhere to GDP and GMP standards. + Identifying training needs by… more
- Boehringer Ingelheim (Athens, GA)
- …reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist , Validation manages all phases of higher level, more complex validation ... requirements and are suitable for their intended purposes. The Principal Specialist , Validation will lead project management efforts for validation activities… more
- Catalent Pharma Solutions (Hanover, MD)
- Job Description **Manufacturing Technical Operations Specialist III** **Summary:** _Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies ... products including AAV and other viral vector-based therapies and vaccines._ The ** Specialist III, MTO** will provide support to Manufacturing Associates to meet… more
- Catalent Pharma Solutions (San Diego, CA)
- **Quality Assurance Specialist , Clinical Supplies** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the ... services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and… more
- Catalent Pharma Solutions (Harmans, MD)
- **Sr. Specialist , QA OTF - Night Shift** **Position Summary** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry ... including AAV and other viral vector-based therapies and vaccines. The Sr. Specialist , QA-OTF is responsible for providing Quality Assurance support for GMP… more
- Cardinal Health (Indianapolis, IN)
- …Quality, GMP compliance and EHS/Radiation Safety practices. + Develop and lead GMP /GDP training of all employees. Follows/ mentors GDP/ GMP requirements. ... effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business… more
- Fujifilm (Holly Springs, NC)
- …North Carolina, United States. **External US** **About the Role** The Sr. Specialist 2, QC Program Management Technical transfer (TT) and Sample Support (SS) ... Specifications in close collaboration with relevant stakeholders, including customers. The Sr Specialist 2, TT/SS interfaces with customers to scope QC Sample Plans… more
- Indorama Ventures (The Woodlands, TX)
- …Management System Experience. + Understanding and/or experience of ISO, RC14001, RSPO and GMP concepts and requirements. + Training and/or experience in FMEA, ... Ventures- Indovinya is looking for a (EHS) Quality Assurance Specialist to join our team in The Woodlands, TX....data analysis, trending and reporting, development programs and administering training , and other as needed. **What will be expected… more
- Fujifilm (Thousand Oaks, CA)
- …will fuel your passion, energy and drive - what we call Genki.** The Specialist QA, Compliance supports the Cellular Therapy GMP quality program. This individual ... energy and drive - what we call Genki.** The Specialist QA, Compliance supports the Cellular Therapy GMP...Risk Management: maintaining the Risk Management SOP and related training , owning and updating the Risk Register, Facilitating Risk… more
- Merck (Rahway, NJ)
- …including the oversight of the Electronic Document Management Systems (EDMS) and training systems, issuance and archival of GMP documentation and revision ... regulatory intelligence, and the Quality Management System (QMS). The Senior Specialist role reports into the Global Quality Systems organization, within CQMS,… more
- ThermoFisher Scientific (Bannockburn, IL)
- …Position summary: Thermo Fisher Scientific Inc. is seeking a highly motivated **Customer Training Specialist ** to lead customer training programs and develop ... **Discover Impactful Work:** **A day in the Life:** As the Customer Training Specialist , you will ensure that our teams adhere to product development and… more
- Post Holdings Inc. (Winchester, VA)
- …affiliated with Thomas H. Lee Partners, LP ("THL"), a private equity firm. Responsibilities Training Specialist About 8th Avenue 8th Avenue is a leading, private ... and effectiveness of such methods. Duties and Responsibilities The Training Specialist is responsible for all things...sessions, and continuously improved. Create, develop and implement new training as needed to support GMP 's. Assist… more