- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma.Legend Biotech is seeking Environment, Health & Safety (EHS) Sr. Specialist as part of the Technical Operations team based in Raritan, ... collaborative team setting with Plant counterparts that include Manufacturing Operations , Engineering and Facilities , Warehouse and Quality.RequirementsBS/BA… more
- Merck & Co. (Durham, NC)
- …Responsible for the quality aspects of good manufacturing practices ( GMP ) computerized systems and the supporting infrastructure used in site ... facilities , utilities, manufacturing, packaging, labeling, and laboratories to ensure...integrity. Work closely with stakeholders and SME's from site operations , quality operations , IT, automation and engineering… more
- Astellas Pharma (Westborough, MA)
- **BioPharma Manufacturing Facilities Compliance Specialist ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? ... headquartered in Massachusetts. Astellas is announcing a **BioPharma Manufacturing Facilities Compliance Specialist ** opportunity at their **Astellas Institute… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Specialist II, MTO** **Summary:** _Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The ... campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington...AAV and other viral vector-based therapies and vaccines._ The ** Specialist II, MTO** will provide support to Manufacturing Associates… more
- Catalent Pharma Solutions (Baltimore, MD)
- …support for GMP Raw Materials that support the production of GMP Manufacturing operations . Responsibilities include providing QA oversight of materials used ... ** Specialist , QA - Raw Materials** **Position Summary** Catalent...regulatory and client audit/inspections and supports internal audits of GMP systems and facilities + Engages with… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …Familiarity with plasma fractionation and purification, aseptic processing, filling, sterilization, GMP regulations, and Quality Operations are desirable. * Must ... of plasma fractionation, protein purification, aseptic processing and filling, sterilization, GMP regulations and Quality operations . + Excellent oral and… more
- Catalent Pharma Solutions (Harmans, MD)
- …Catalent employee. **The Role:** * Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug ... ** Specialist , QA OTF** **Position Summary** Catalent is a...oversight * Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal… more
- Astellas Pharma (Westborough, MA)
- …serves as the Mfg. Technical Subject Matter Expect (SME) for Mfg. Operations . **Organizational Context:** The Sr. Specialist , Manufacturing, will typically ... **Sr Manufacturing Specialist , Production Planning** Do you want to be... role is responsible for the support of manufacturing operations and based on location, will typically be assigned… more
- PCI Pharma Services (Bedford, NH)
- …network to pioneer and shape the future of PCI. Job Summary: The QA Specialist will work with other departments to ensure the quality of products and compliance ... and other investigations in support of batch release and GMP compliance + Provide direction for complex investigations and...experience with 2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production… more
- Endo International (Rochester, MI)
- …and production support areas to process sterile and aseptic products. The specialist works in collaboration with Operations , Maintenance, Engineering, Supply ... to join our team. **Job Description Summary** The Associate Process Engineer, Prep Service Specialist , works in a hands-on capacity in a fast-paced, cGMP environment… more
- Fujifilm (Thousand Oaks, CA)
- …energy and drive - what we call Genki. The QC Instrumentation Specialist will a** **uthor, review, approve laboratory procedures, instrument validation, CAPAs, ... control assessments as they pertain to lab instrumentation.** **External US** ** Specialist Quality Control - QC Instrumentation** QC Instrumentation Specialist ,… more
- Merck (West Point, PA)
- …improvements and troubleshoot process equipment to ensure reliable, compliant and efficient operations + Actively ensures GMP quality, safety, environmental, and ... Description** Are you a motivated and experienced Engineering Maintenance & Utilities Specialist looking for a challenging and rewarding opportunity? Do you have a… more
- Bristol Myers Squibb (Summit, NJ)
- …here at BMS with our Cell Therapy team. The **Training & Development Specialist ** is responsible for the successful implementation of the site Manufacturing Training ... Program. The Specialist assists in determining training solutions that adhere to...training are continuously applied. + Implements the local Manufacturing Operations new hire Training Program including: + Promotes and… more
- Novo Nordisk (Fremont, CA)
- …for improved treatment of Type 1 Diabetes and other chronic diseases. The Specialist will provide technical expertise and perform various tasks in a manufacturing ... environment in compliance with cGMP regulations. The Specialist will help in the development of new processes,...in processing methods, aseptic technique, and cGMP clean room operations + Write and/or revise master production records, SOPs,… more
- Lilly (Concord, NC)
- …Assurance Floor Support Specialist is responsible for providing QA oversight to GMP operations . The role will provide QA support of the startup, ... capacity in parenteral (injectable) medications, device assembly and packaging operations . This is an exciting once-in-a-lifetime opportunity to help build… more
- State of Georgia (Fulton County, GA)
- Dairy Compliance Specialist 1, 2 or 3 Georgia - Fulton (https://careers.georgia.gov/jobs/57104/other-jobs-matching/location-only) Regulatory ... and the Code of Federal Regulations (CFR). . The dairy compliance specialist collects samples, reviews sanitation practices, reviews records, and product labels… more
- Catalent Pharma Solutions (Hanover, MD)
- **Sr. Specialist , QA - Batch Disposition** **Summary:** _Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the ... Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from… more
- Astellas Pharma (Sanford, NC)
- ** Specialist , Quality Assurance** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to ... under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information,… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are hiring a QA Specialist for our Technical Transfer Start Up Team (TTST). As a QA Specialist you will provide QA oversight in the TTST to ensure ... approval of investigations associated with raw materials, product, laboratory, facilities , and materials. + Continually evaluating Regeneron processes and procedures… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- … Specialist position. This position will support Visual Inspection operations performed at Regeneron's Internal Fill/Finish facility. This position will provide ... at the Drug Product facility. + Ensure that facilities , equipment, materials, processes, and procedures comply with applicable...critical thinking skills to ensure quality and compliance to GMP regulations for all area operations and… more
