- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. Durham's Technology Transfer Specialist will be an energetic, technical leader with strong interpersonal, ... and collaboration skills responsible for implementation of technology transfer process knowledge, post approval support, and post commercial process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Operations Support Specialist , Sun-Wed 2nd Shift as part of the Technical Operations team based ... in Raritan, NJ. Role OverviewThe Operations Support Specialist will be part of the Technical Operations team...support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Validation Specialist III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Validation Specialist role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification… more
- Aequor (Thousand Oaks, CA)
- …functions that enable the B20 plant to add value to the network: Manufacturing, Process Development , Supply Chain, Quality, and Facilities & Engineering. A high ... work alongside other innovative, driven professionals in this meaningful role. Role: Specialist Manufacturing, New Product Introduction Let's do this! At we strive… more
- CSL Plasma (Waukegan, IL)
- …to operational quality management Collaborate with center management in the development and implementation of continuous improvement plans Collaborate with Assistant ... of correcting or improving operational or quality issues. Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation… more
- Scientific Protein Laboratories (Waunakee, WI)
- …pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients ... to join the team as a Manufacturing Documentation and Compliance Specialist . This position supports manufacturing operations by ensuring accurate documentation, data… more
- Planet Pharma (Newbury Park, CA)
- …accuracy and completion of data entries and/or tasks for budget development , monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), ... or packaging manufacturing environment. 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles. 2+… more
- Staff Icons LLC (San Diego, CA)
- …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...error events. Perform supervisory evaluation of QIRs. Oversee Q&D process for lab. Assist with department staff meetings and… more
- University of Southern California (Los Angeles, CA)
- … (PD) SpecialistApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ cGMP - Process - Development --PD-- ... cell and gene therapies and other biological products for internal/external users. The Process Development (PD) Specialist is responsible for developing… 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 Principal Specialist , CSVC oversees all aspects of computer system and computer system and… more
- Belcan (Durham, NC)
- …and quality assurance/control documentation. * Assists in the development of cGMP operating procedures that relate to process , computer systems, and ... Validation Quality Specialist Job Number: 358838 Category: QA /QC Description:...Referral program Responsibilities: * Ensures current Good Manufacturing Practices ( cGMP ) and Quality Systems are adhered to throughout the… more
- Merck (Durham, NC)
- …several years; currently Durham employs 1,000+ people. Durham's Technology Transfer Specialist will be an energetic, technical leader with strong interpersonal, ... and collaboration skills responsible for implementation of technology transfer process knowledge, post approval support, and post commercial process… more
- Fujifilm (College Station, TX)
- …**_Summary:_** FUJIFILM Biotechnologies in Texas is seeking a Senior eQMS Specialist to support the configuration, implementation, analysis, and maintenance of the ... Quality Management Systems (eQMS). This role ensures system compliance with cGMP and regulatory requirements while optimizing eQMS functionality and efficiency. The… more
- Catalent Pharma Solutions (Harmans, MD)
- …and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage ... **Senior Specialist , QA OTF - PM Shift (7pm-7am)** **Position...**Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to… more
- Abeona (Cleveland, OH)
- …Report to management as needed. + Work with the Manufacturing, Quality Control, Assay Development , and Process Development departments as a production area ... document management ensuring procedural and regulatory compliance throughout the manufacturing process . The Senior Specialist I, Quality Assurance will report… more
- Catalent Pharma Solutions (Harmans, MD)
- …and a warehouse._ _The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage ... ** Specialist II, MTO** **Summary:** _Catalent, Inc. is a...manufacturing processing in a GMP compliance environment (eg Production, Development , Process Engineering, Technical Services or related… more
- Catalent Pharma Solutions (Harmans, MD)
- …and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage ... **Lead Specialist , QA Validation & Engineering** Catalent Pharma Solutions...Harmans, MD Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to… more
- Adecco US, Inc. (Swiftwater, PA)
- …characterization, take lead in high throughput gene synthesis and plasmid production, process automation and protocol development , improvement of quality and ... Healthcare & Life Sciences is hiring a contract Project Specialist for our Pharmaceutical partner in Swiftwater, PA. The.... Investigate and correct safety standard deviations . Support cGMP compliance and participate in new team member training… more
- Kelly Services (Warwick, RI)
- …environment for Manager Level + A minimum of 5 years working in a cGMP regulated environment for Sr Specialist Level + Experience supporting quality oversight ... **Sr. Specialist , External Quality Small Molecules (Remote)** **Manager or...and complaints, including review and approval of non-conformances and development of robust CAPA plans. Provide support to the… more
- PACIV (San Juan, PR)
- …its Puerto Rico office. Job Description: The Computerized System Validation (CSV) Specialist /Engineer will be responsible for development and execution of ... Industry, mainly Bio-Pharma and/or Medical Devices. The resource will be responsible for development and execution of CSV deliverables, as per System Development … more
