- Novo Nordisk Inc. (Boulder, CO)
- …2021. With a new laboratory completed in 2021 to support analytical and process development , the CMC team works alongside Quality, Regulatory, Technical ... , API Manufacturing reports to the Senior Manager, API Manufacturing. The Specialist , API Manufacturing works with Chemical Development , Analytical Services,… more
- Merck & Co. (Rahway, NJ)
- …the broader Enabling Facilities Automation Team supporting facility operations, process development activities, compliance investigation, change management and ... of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial… more
- Catalent (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
- Merck & Co. (Rahway, NJ)
- …Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work ... job that provides both technical and project management responsibility. The Specialist - Manufacturing Automation position will report to the Director, Engineering,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma. Legend Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ. Role Overview The ... QA Warehouse Incoming/Raw Material Specialist is an exempt level position with responsibility to...for clinical trials and commercial operation in a controlled cGMP environment. Reviews, inspection, and disposition of all incoming… more
- Catalent (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 ... create engaging new products consumers will love.The Document Control Specialist - 2nd Shift is responsible for creating and...any other documents as required.Manage the routing and approval process for new documents and process deviations;… more
- Aequor (Seattle, WA)
- …cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the ... Above-site organization, including the document approvals, document change control process , periodic review and system reporting. Duties/Responsibilities: Primary responsibilities… more
- Merck & Co. (Rahway, NJ)
- …of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial ... The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization.- The pilot plant's mission is… more
- Merck & Co. (Rahway, NJ)
- …Automation Engineer, you will play a crucial role in supporting the process automation systems within clinical manufacturing.-The Automation Specialist - ... Rahway NJ facility. The Auto Eng Team is responsible for the development of new technologies/capabilities, execution of capital and non-capital improvement projects,… more
- Catalent (St. Petersburg, FL)
- …for managing and documenting events / discrepancies associated with either product or process as well as managing / writing any investigations that may be a ... and Standard Operating Procedures through the periodic inspections and monitoring of process controls in all applicable areas of the manufacturing operation. The… 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
- Mayo Clinic (Rochester, MN)
- …and external clients. Scope of the position includes effectively contributing to CGMP development and manufacturing teams during the planning and execution ... The candidate will be responsible for performing manufacturing operations, including process development , pre-clinical production processes, and GMP processes… more
- Mayo Clinic (Rochester, MN)
- **Responsibilities** The Biomanufacturing Specialist Lead is the primary process development and/or manufacturing expert supporting the production of ... internal and external clients. Scope of the position includes effectively leading CGMP -related development and manufacturing teams during the planning and… more
- Mayo Clinic (Rochester, MN)
- …**Responsibilities** The Biomanufacturing Specialist Lead is the primary process development and/or manufacturing expert supporting the production of ... Lead will be responsible for managing manufacturing operations, including process development , pre-clinical production processes, and GMP processes for… more
- ThermoFisher Scientific (Bend, OR)
- **Job Description** **Job Title:** Quality Assurance Specialist III / Data Integrity Compliance Officer **Last Review Date:** 04Jan2021 **Summary** Supports the ... resolving Data Management issues. **Essential Functions** Assures compliance with cGMP regulations, Thermo Fisher standards, and applicable regulatory requirements.… 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
- J&J Family of Companies (Lititz, PA)
- …in internal and external audits * Acts as an SME for Investigation/CAPA process * Provides cGMP compliance guidance and delivers training/capability building to ... Production Quality Specialist (Oral Care) - 2407018318W **Description** Kenvue is...Regulations (CFR) 210 and 211 Current Good Manufacturing Practices ( CGMP ) regarding quality methods and manufacturing and packaging processes… more
