- Actalent (Irvine, CA)
- …seeking a dedicated Quality Assurance Specialist to ensure compliance with cGMP regulations and standard operating procedures. The role involves coordinating ... documentation quality and maintain Quality Systems. Responsibilities + Comply with cGMP regulations and all standard operating procedures. + Assist in ensuring… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …with quality compliance groups, strategically meet goals and lead External Manufacturing cGMP Policies and SOPs + Leads and prioritizes operations and practices for ... Regeneron audits + Provides expertise to the global External Manufacturing organization on cGMP compliance standard processes, as well as, new and developing cGMP… more
- Lilly (Indianapolis, IN)
- …improvement of existing manufacturing methods via Current Good Manufacturing Practices ( cGMP ). Roles and Responsibilities of the Position: + Produce radioisotopes ... and drug products following cGMP guidelines and resolve all production-related quality events in...and complete lab data notebooks as per cGLP and/or cGMP , as appropriate. + Adhere to all applicable procedures,… more
- Aerotek (Brookhaven, NY)
- …hour) **Description** Operate and monitor manufacturing equipment in compliance with cGMP standards. Follow Standard Operating Procedures (SOPs) to ensure consistent ... of equipment as needed. **Skills** Set up machine, Mixing, Blending, Cgmp , Pharmaceutical manufacturing, Compression molding, Machine operation, Change over **Top… more
- Takeda Pharmaceuticals (Brooklyn Park, MN)
- …role:** As a Material Handler I, you will perform duties in our cGMP warehouse and manufacturing clean room environments. You will monitor inventory levels, order, ... or equivalent required. + 1+ years of experience working in a cGMP warehouse environment preferred. + Proficient in speaking/reading/writing English and performing… more
- Kelly Services (Colorado Springs, CO)
- …transfer, process mapping, and documentation best practices **Pilot Plant & cGMP Operations Management** + Oversee cGMP -compliant pilot plant operations, ... and scalability **Quality Assurance & Regulatory Compliance** + Ensure strict adherence to cGMP (21 CFR 210/211) and data integrity (21 CFR 11) regulations + Develop… more
- Cambrex High Point (Longmont, CO)
- …necessary to perform assigned tasks. + Responsible for ensuring compliance with cGMP and other regulatory guidelines. + Perform assigned tasks carefully, safely, and ... monitoring of bulk drug substances and drug products under cGMP requirements. + Generate hand-written records of actions accurately...+ Demonstrates understanding of the purpose and principles of cGMP and follows cGMP procedures with few… more
- Cambrex High Point (Longmont, CO)
- …Properly operates, sets-up and breaks-down production equipment. + Maintains cGMP suites readiness for manufacturing activities including consumable allocation, ... + Perform basic math calculations. + Assists with batch records for cGMP manufacturing under direct supervision. + Other duties as assigned. Qualifications/Skills +… more
- Amgen (Holly Springs, NC)
- …upstream or downstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance. Please note; no relocation ... direction, the Associate will support all floor operations in accordance with cGMP practices. **Responsibilities will include ** **Compliance:** + Completes work in… more
- PCI Pharma Services (Bedford, NH)
- …including chemicals, reference standards, and consumable materials in accordance with cGMP and procedural requirements + Inspection, review and receipt of incoming ... + Maintain sample tracking and chain of custody records in accordance with cGMP and procedural requirements + Complete data entry in validated systems and business… more