- Legend Biotech USA, Inc. (Raritan, NJ)
- … cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference for Cell/Gene Therapy ... clinical and commercial requirements in either a Grade C or sterile cGMP environment.Key Responsibilities Oversee cell therapy production and ensure safe and… more
- Merck & Co. (Rahway, NJ)
- …Product/sterile experience. Required Experience and Skills :-Strong familiarity with Quality , cGMP , Safety & Environmental Policies and Procedures.Familiarity ... and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support, ensuring facility, utilities and equipment are… more
- Omni Inclusive (Summit, NJ)
- …when manager requests) The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise ... production works. The Specialist will partner with site Business Owners, CI Owners, Quality , and the global EMES team to create, manage, and improve computerized… more
- Bristol-Myers Squibb Company (Indianapolis, IN)
- …with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice ( cGMP ). The Senior Manager provides Quality support and ... be the global leader in radiopharmaceuticals. Summary The Senior Manager , QA for QC is responsible for quality...review, method development, validation , and transfer, equipment validation , and associated projects. The Senior Manager … more
- Integrated Resources, Inc. (New Brunswick, NJ)
- Job Title: Quality Manager Job Location: New Brunswick, NJ, 100% onsite Job Duration: 6 Months (possibility of extension) Shift: Mon- Fri (normal business hours) ... with review of change proposals, Quality Agreements, Annual Product Quality Reviews, and validation documentation as needed. Participate in investigations,… more
- DuPont de Nemours, Inc. (Hemlock, MI)
- …professional to join our Industrial Solutions business on a full-time, direct basis as our Quality Manager at our facility in Hemlock, MI. We are looking for a ... to the Quality Management System [QMS] to meet healthcare market quality requirements (including Current Good Manufacturing Practice [ cGMP ] standards). This… more
- Abbott (Buffalo Grove, IL)
- …and international sites for finished device manufacturing including yield and quality data reports, finished device acceptance, validation , external inspections, ... Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Sr. Manager , Third Party Manufacturing Working at Abbott At Abbott, you can do work… more
- Selux Diagnostics (Boston, MA)
- …manufacturer in the northern California area. This effort includes installation, commissioning, validation , maintenance and repair of the system, as well as testing, ... through WIs and SOPs. Candidates will report to the Manufacturing Engineering Manager and work within the Selux Operations team. Candidates will collaborate… more
- Biomerics (Minneapolis, MN)
- …DESCRIPTION: We are seeking a technically proficient and hands-on Technical Extrusion Manager to lead extrusion engineering efforts at our Brooklyn Park, MN ... facility. This role is responsible for supporting the development, validation , and production readiness of medical device tubing processes. The ideal candidate will… more
- BioSpace (Bridgewater, NJ)
- …will have accountability to their packaging projects to assure they meet quality and consumer expectations while maintaining project schedule and budgets. Under ... limited manager supervision,... supervision, the individual will also work closely with quality , finance, procurement, regulatory, engineering, operations, consultants and outside… more
- Staff Icons LLC (San Diego, CA)
- …hiring, and training of new personnel. Supports the Lab Management Team, safety, cGMP and Quality Plan. Responsibilities Adheres to current good manufacturing ... practices ( cGMP ) guidelines. Adheres to CUA, AABB, FDA, and other...work load and prioritization. Assist Management with the Laboratory quality control, maintenance and validation processes. Assist… more
- Actalent (Cranbury, NJ)
- …you will contribute to solving problems, reviewing experimental data, writing protocols/SOPs/ validation reports, and training support staff as necessary. You will ... monitor study procedures to ensure data accuracy and report quality while maintaining a GMP/GLP laboratory. Responsibilities Conduct analysis in compliance with … more
- Eurofins (San Ramon, CA)
- …and the function of the laboratory Conduct timely investigations in coordination with Quality Assurance related to site quality events, including, but not ... duties in compliance with all applicable regulatory and accrediting agencies and cGMP expectations, including but not limited to: Facility and equipment maintenance,… more
- Evonik Industries (Birmingham, AL)
- …external engineering services and suppliers, Tech Ops, R&D, Manufacturing, Maintenance, Procurement, Quality , Supply Chain, and Validation depending on the scope ... and grow alongside 33,000 colleagues. Among attractive career paths and high- quality development programs, we not only offer performance-based remuneration and… more
- Honeywell (Baton Rouge, LA)
- The Quality Assurance (QA) Manager oversees, implements, and maintains cGMP compliant systems and activities. Incumbent is also responsible for evaluating ... internal controls and maintenance of cGMP documentation for compliance with quality and regulatory standards. The GMP QA Manager also monitors Contract… more
- Bristol Myers Squibb (Indianapolis, IN)
- …entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is ... address process deficiencies. Work collaboratively with peers within various departments and Quality groups. + Provides validation subject matter expertise (SME)… more
- BeOne Medicines (San Carlos, CA)
- BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Senior Manager , Systems Validation in San Carlos, CA: **Job Duties:** Manage the entire GxP change control process ... and revise accordingly based on guidance and feedback from Quality team. Manage validation activities of cross...21 CFR Part 11, 210 & 211, GLP, GCP, cGMP (current Good Manufacturing Practice) regulations. Any suitable combination… more
- Curia (Rensselaer, NY)
- …in a cGMP regulated industry specific to computer systems validation + Validation experience in a cGMP quality control laboratory or sterile fill ... Quality team. This role is responsible for supporting Quality Management Systems and Computer System Validation ...date trainings + Other duties as assigned by QA manager and/or QA director Education and Experience: + Bachelor's… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …formulation. The **Senior Validation Specialist** with guidance from the Validation Manager , defines and implements procedures and processes to assure ... that pertain to Installation, Operational, and Performance Qualification. + Assuring cGMP compliance related to Qualification and Validation of… more
- PCI Pharma Services (Rockford, IL)
- …resolution of corrective action to complete the project. Primary contact for quality validation activities and managing expectations. Reviews and interprets ... meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager . Investigate validation... protocols. Knowledge of and adherence to all PCI, cGMP , GCP, GAMP, 21CFR, 21CFR Part 11, and Annex… more
