- Catalent (San Diego, CA)
- …troubleshoot technical issues.Collaborate with Quality Assurance and Quality Control on analytical method validation and compliance issues. ... qualification studies to determine if methods are suitable for transfer to Quality Control .Communicate results both internally and externally through oral and… more
- Merck & Co. (Durham, NC)
- …bulk active ingredient, finished product, and laboratory testing. - The Senior Specialist, Quality Control participates in a team of analysts in the development, ... - 10:30 pm) - Job Responsibilities The Senior Specialist, Quality Control will be accountable for activities...for activities that support cGMP and regulatory compliance during method qualification/ validation and routine product testing to… more
- Aequor (NV)
- … method implementation team responsible for method transfer and method validation to Quality Control for pivotal and late stage programs. The role ... 3&plus years of pharma/biotech experience *Biotech/ pharma experience required) * Analytical method validation and transfer experience Ideal candidate with a… more
- Insmed Incorporated (San Diego, CA)
- …CMC team.Perform quality management activities such as deviation, CAPA, change control , investigation of OOS, OOT and anomalous results within the company QMS ... to AAV gene therapy products. The scientist will be involved in transfer of method from Analytical Development into QC. The scientist will author and execute phase… more
- Merck & Co. (Durham, NC)
- …energize individuals at all levels in the organizationFUNCTIONAL EXPERTISE: The Specialist, Quality Control will be responsible for activities that support cGMP ... candidate will participate in equipment validation , process validation , and GMP laboratory readiness.- The Quality ...and regulatory compliance during method qualification/ validation and routine product activities to… more
- Catalent (St. Petersburg, FL)
- …partnership with other functional areas (eg Product Development, Operations, Customer Service, Validation , Quality Control , etc.) to ensure continued ... recipes, various technical protocols (Pre-Commercial Clinical Packaging Protocols, Process assessment, Method Validation , Bulk Mfg Protocol and Reports (non-GMP,… more
- Tris Pharma (Monmouth Junction, NJ)
- …takes a leadership role for other chemists on the QA R&D team in supporting Quality Control (QC) and Analytical R&D (AR&D) activities. These include but are not ... methods etc. Collaborating closely with Analytical Research and Development (AR&D) and Method Validation teams, the incumbent develops and demonstrates advanced… more
- Catalent (San Diego, CA)
- …interactions, and communications with client QA counterparts. Site Recall/ Quality alert program, Facility/equipment/process/analysis method /cleaning ... Senior Manager, Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA...and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for… more
- Merck & Co. (Rahway, NJ)
- …of product design and development; manufacturing process development, qualification, and validation ; and, design control and risk management techniques to ... analysis and testing, medical device design controls, risk management, test method /fixture development, design verification and validation , injection molding,… more
- Tris Pharma (Monmouth Junction, NJ)
- … Quality Assurance (QA) Research and Development (R&D) Analytical Chemist supports Quality Control (QC) and Analytical R&D (AR&D) activities by initiating ... softwareExperience with wet chemistry and chemistry related to sampling methods, quality control systems, analysis and documentation practices and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …realize your potential? The Position This position has primary responsibility to support Quality Control (QC) operations in the microbiology area. This position ... Promotion Testing) Completes routine equipment maintenance May support equipment calibration/ validation or method verification Participates in systematic problem… more
- Tris Pharma (Monmouth Junction, NJ)
- …biotechnology industry working in Analytical Research and Development (AR&D), Method Validation (MV) and/or Quality Control (QC) or related ... reviews and revises SOPs related to metrology activitiesInitiates change control related to analytical instrument Assesses critical analytical instrument/equipment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …counterparts that include Manufacturing Operations, Quality Assurance, Engineering and Validation , Quality Control and Warehouse Operations. Requirements ... in clinical manufacture or NPI is preferred. Experience in clinical quality , method development, cell banking, or Research & Development is preferred. Proficient… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …North Carolina, United States. External US About This RoleThe QA Engineer for Quality Control (QC) Compliance will be responsible during the project phase, ... applicable industry experience 3+ years of experience in GMP Quality Assurance and/or similar role Experience in Validation...FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM,… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …Requirements:BS/BA or equivalent and 6+ years applicable experienceExperience in Validation , cGMP manufacturing operations and/or Quality oversight, in ... QA Engineer will be responsible to partner in the Quality oversight of IT and Automation (OT) systems through...to operational readiness, as well as provide oversight of validation program execution for these systems. You will collaborate… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …of the LIMS procedures. The QC LIMS Sr. Specialist 1 works closely with Quality Control , Analytical Development, Manufacturing and Quality Assurance to ... procedures Provides LIMS training, technical support, problem reporting and resolution(s) to Quality Control laboratory, QA, AD and Manufacturing staff, as… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …for participating in the Technology Transfer of raw material methods into FDBN Quality Control Laboratory, with limited supervision. This includes onboarding of ... manufacturing. Provide technical knowledge to assess testing approach, verification and validation needs both internally and at external contract labs. Performs QC… more
- Nesco Resource (Austin, TX)
- …the effort of Supplier Quality Engineering team by helping improve product quality , mitigate, control and resolve supplier quality issues.-Reviews and ... Job Description: The Supplier Quality Technician is primarily responsible for supporting Supplier...activities such as supplier assessment, supplier/product qualification and test method alignment.-May also be asked to support process and… more
- FUJIFILM Holdings America Corporation (Holly Springs, NC)
- …, transfer, commercialization, and manufacturing support and troubleshooting Experience using quality systems (eg, deviation management system, change control , ... functional communication to key stakeholders Supports Chemistry, Manufacturing and Control (CMC) activities for development and manufacturing, as required Supports… more
- FUJIFILM Holdings America Corporation (College Station, TX)
- …the hub of innovation, representing a source of pride for the area.The Quality Control Chemistry Supervisor, under general supervision, will be responsible for ... maintained in a qualified state.Prepare and execute tech transfer, qualification and validation protocols and reports as needed. Write, revise, and review Standard… more
