- Dexian - DISYS (Bothell, WA)
- …within a regulated cGMP environment. The primary focus of the QA Specialist role will be to support routine clinical and commercial production to ensure ... cross-functional experience, strong interpersonal skills *Job Description: The Quality Assurance Specialist position plays a key role in supporting the cGMP… more
- Integrated Resources, Inc (Bothell, WA)
- …annotations within EDMS experience The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the ... Job Title: QA Document Control Labelling Specialist Location: Bothell, WA Duration: 6 months+ Pay...Client site, including the document change control process , issuance and reconciliation of batch records, batch related… more
- University of Southern California (Los Angeles, CA)
- …in the university's current Good Manufacturing Practices ( cGMP ) facility. The Process Development Specialist is responsible for developing procedures and ... Process Development SpecialistApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ cGMP - Process - Development - Specialist \_REQ20145450/apply) Keck School… more
- Unither Pharmaceuticals (Rochester, NY)
- …company SOPs and industry standards. Provides Quality oversight to the drug development process , including safety, toxicity and regulatory compliance and the ... Quality Specialist - Development & Validation Who...maintain partnerships with internal teams and external organizations supporting development , technology transfer, process validation, and commercialization… more
- Merck (Durham, NC)
- …We are seeking a Growth and Improvement minded Quality Control Laboratory Associate Specialist that can help drive our Strategic Operating Priorities. + Invent | ... and support laboratory testing for vaccines. The Quality Control Laboratory Associate Specialist participates on a team of analysts in the method transfer,… more
- Merck (Durham, NC)
- …skills responsible for supporting IQ and OQ while specifically providing cycle development and Process Qualification (PQ) for equipment and systems supporting ... documentation. + Develop technical and manufacturing documents necessary for development studies, cleaning, sanitization, depyrogenation and sterilization process… more
- Cardinal Health (Fort Lauderdale, FL)
- …Health's Nuclear and Precision Health Solutions organization tasked with the development and technology transfer of radiopharmaceutical products into and among our ... quality functions at the PET manufacturing site, such as: + Handles cGMP documentation review related to product release, facilities and equipment, material… more
- Kedrion Biopharma, Inc. (Melville, NY)
- …in hematology, immunology, neurology, and transfusion medicine. The Quality Operations Specialist has a robust understanding of applicable CGMP regulations ... Kedrion Biopharma is a biopharmaceutical company specializing in the development , production and distribution of plasma-derived products. Kedrion has been producing… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- Job Title Sr. Process Safety Specialist - Onsite Requisition JR000014049 Sr. Process Safety Specialist - Onsite (Open) Location St. Louis, MO (Pharma) - ... and processes to continually improve the organization's safety culture. The Sr. Process Safety Specialist will directly support site needs for developing,… more
- ThermoFisher Scientific (Plainville, MA)
- …Plainville) business unit of Thermo Fisher Scientific. At VVS Plainville, we deliver process development through commercial supply and offer the expertise and ... genetic, rare, and otherwise untreatable diseases. **Discover Impactful Work:** The Procurement Specialist III reports to the Sr. Manager Procurement into the Viral… more
- Merck (Wilson, NC)
- …investigations, approve investigations, Annual Product Reviews, regulatory document reviews, process change request activities, SOP development and review, ... general direction of the Associate Director, Wilson Quality Operations, the Specialist is primarily responsible for support of Quality Assurance activities within… more
- Regeneron Pharmaceuticals (Troy, NY)
- …timely completion of associated operations/documentation, and assisting in the monitoring of cGMP compliance. As a Principal Specialist within the Bulk External ... manufacturers or business partners. + Leads a sub-team in continuous process improvements, system/equipment implementation and/or strategy development . +… more
- ThermoFisher Scientific (San Francisco, CA)
- …Fisher Scientific's broad portfolio of solutions and clinical and commercial cGMP cell therapy manufacturing services, along with associated technology ... development support to our partners. In the Cell Therapy...for a variety of unmet medical needs. The QA Specialist III will provide Quality oversight for projects, performs… more
- Catalent Pharma Solutions (Manassas, VA)
- …supplements and nutraceuticals, as well as small batch lozenges. With extensive development and manufacturing expertise and a wide range of flavors, ingredients, and ... to help create engaging new products consumers will love. The **Quality Assurance Specialist I - Quarantine** is responsible for auditing the products and processes… more
- Bausch Health (Bridgewater, NJ)
- …of improving people's lives with our health care products. The **Senior Specialist , External Manufacturing Quality** plays a crucial role in upholding compliance ... devices/combination products, consumer products/OTC, and biologics sectors, ensuring adherence to cGMP regulations and Bausch Health requirements. With a keen eye… more
- Boehringer Ingelheim (Athens, GA)
- …to assess the quality / compliance of current Good Manufacturing Practice ( cGMP ), applicable regulations, and applicable company policies and procedures. May support ... contractors on behalf of the BI manufacturing world, including Operations, Development , Biopharma, and Animal Health. Ensures corrective measures are implemented.… more
- Boehringer Ingelheim (St. Joseph, MO)
- …an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development , and delivery of our products to our patients and customers. Our ... programs reflect Boehringer Ingelheim's high regard for our employees. The Specialist , Production Execution Systems works daily with the core data, monitoring… more
- Hovione (East Windsor, NJ)
- …reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and ... it for life. You will be responsible to: Guarantees cGMP compliance in all activities and systems related to...documents (PdAs) as required and appropriate - Approve IOPs, process master documentation and product specifications as required and… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Analytical Quality Assurance Specialist Department: Analytical QA Location: Monroe, NC START YOUR APPLICATION ... New Biological Entities (NBEs'), with eight molecules in various stages of clinical development . Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US… more
- Catalent Pharma Solutions (Greendale, IN)
- **Quality Assurance Specialist II** **Position Summary** Welcome to Greendale, Indiana! Greendale is one of two gummy technology development and manufacturing ... plant-based pectin gummies for nutritional supplements and nutraceuticals. With extensive development and manufacturing expertise and a wide range of flavors,… more
