- Curia (Albany, NY)
- …principal responsibility is to manufacture batches of intermediates and APIs under cGMP protocols. We proudly offer + Generous benefit options (eligible first day ... as providing answers to questions related to scale-up knowledge, cGMP procedures, and Curia policies + Maintain knowledge on...a timely basis + Manage all aspects of a cGMP manufacturing campaign, including batch record review, safety evaluations,… more
- AbbVie (Waco, TX)
- …manner and complete all required documentation in accordance with cGMP 's and department SOP's. Maintain equipment functionality through preventative maintenance ... Perform all assigned duties according to departmental SOP's and cGMP 's. + Remain current on proper procedures by reviewing...department. + Complete and remain current with all required cGMP and safety training. + Perform maintenance and repairs… more
- Catalent Pharma Solutions (Harmans, MD)
- …life-enhancing and life-saving treatments for patients annually. Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the ... and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The… more
- BeOne Medicines (Pennington, NJ)
- …facility and then shift focus to hands-on execution and support of cGMP manufacturing operations. **Hands-On cGMP Operations** : Focused on execution ... Essential functions of the job include but not limited to: + Follow cGMP procedures to support manufacturing execution and automated recipes + Clean-In-Place (CIP) &… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …primary Quality Assurance activities for Teardown, Fractionation, and Purification following cGMP , GDDP, FDA and Regulatory Standards, ISO requirements, and internal ... compliance to procedure, Quality on the Shop Floor walkthroughs to assure cGMP compliance and resolution of issues, participating in troubleshooting and problem… more
- University of Miami (Miami, FL)
- …engaged in the operational and research and development (R&D) functions of the cGMP human cell processing division. Expected to have primary responsibilities for the ... + Responsible for overseeing all equipment management activities for cGMP operations, including Installation Qualification (IQ), Operational Qualification (OQ),… more
- Jabil (Hunt Valley, MD)
- …Data Reviewer I will verify compliance with Good Manufacturing Practices ( cGMP ), Good Laboratory Practices (GLP), and related company standard operating procedures ... to improve analytical data reporting, adhering to GDP and cGMP to increase efficiency, compliance, and Quality. + Review...errors and omissions in GMP documentation and promote a cGMP culture. Ability to pay attention to detail, focus,… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …the highest quality standards. + Maintain documentation and functional work areas to CGMP standards. + Capable of lifting and moving heavy equipment parts and ... good manual dexterity. + Must possess basic knowledge of CGMP -s. + Must be able to transcribe detailed data...be able to transcribe detailed data accurately according to CGMP and SOP standards. + Must be able to… more
- Abeona (Cleveland, OH)
- …responsible for working independently and with others on activities that support cGMP Manufacturing. These tasks include, but are not limited to autoclaving, ... for basic Quality Management System (QMS) support. Associates will maintain cGMP training, perform routine facility and equipment maintenance, and train in… more
- Cambrex High Point (Longmont, CO)
- …The Manager in Drug Substance Manufacturing Operations works in a regulated cGMP environment within a Quality Management System and plays an important leadership ... for ensuring department and staff compliance with and enforcement of all cGMP SOP's, Safety SOP's, site-specific policies, and procedures + As needed, establish… more