- 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
- 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
- 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 or analytical area. ... ELISA, UPLC) Completes routine equipment maintenance May support equipment calibration/ validation or method verification Participates in systematic problem… 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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …such as residual and PCR-based assays).Strong background in analytical control strategy development and execution.Demonstrated ability to develop talent through ... in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics… more
- South Shore Health (Weymouth, MA)
- …high quality test result records as evidenced by data review, Quality Control , Proficiency Testing, CAP Inspections, and feedback from clinician.f. Assures ... Competency of Staff in interpreting Quality Control Data.g. Develops comprehensive systems to monitor the quality of work. This plan (QC, QA, & Proficiency… more
- Editas Medicine (Cambridge, MA)
- …for characterization and validation studies. + Manage the review and approval of quality control method validation protocols and associated reports. ... and expertise to CMC and Tech Transfer teams. + Represent the Quality Assurance Validation group in project teams, audits, and inspections. + Contribute to the… more
- Actalent (Noblesville, IN)
- …Voltammeter, Autotitrator, HPLC, GC, IC, ICP, Flame AA, TOC, Conductivity Meter. + Skills: Quality Control , Method Validation , Chemistry, Method ... HIRING: Sr. Quality Control Tech (Pharmaceutical Experience Summary:...to Safety/ Quality guidelines and SOPs. + Analytical Method Validation and Verification (USP Compendial and… more
- HonorHealth (Scottsdale, AZ)
- …and Urinalysis or Chemistry and Immunohemotology. Responsibilities include quality control , method and instrumentation validation , developing and ... area in compliance with regulatory and inspection standards. Maintains a quality control program, including inter-laboratory comparisons, precision checks and… more
- Catalent Pharma Solutions (San Diego, CA)
- …technical issues. + Collaborate with Quality Assurance and Quality Control on analytical method validation and compliance issues. Familiarity with ... qualification studies to determine if methods are suitable for transfer to Quality Control . + Communicate results both internally and externally through oral and… more
- PCI Pharma Services (Rockford, IL)
- …duties may be assigned. + Write, review, and/or execute validation documentation (eg, Installation/Operation/Performance/Test Method Qualification protocols, ... validation . + Participate in the change management process, outline requirements for validation through impact assessments, and prepare change control and … more
- Abeona (Cleveland, OH)
- …but are not limited to: Master Production Records, Quality Control test methods/forms, Method Qualification/ Validation records, etc. Authorization ... - Operations or above and will support manufacturing and quality control as the production area ...disposition pending issues to management. + Review qualification / validation protocols and reports and ensure resolution of and… more
- Actalent (Aurora, OH)
- …manufacturing - Review analytical documents such as test methods and protocols, lead method transfer to Quality Control laboratory - Will routinely ... Chemistry, Hplc, uplc, Gmp, Laboratory, Analytical chemistry, Formulation, Method validation , Development, Wet chemistry, waters hplc, empower, Quality … more
- embecta (Andover, MA)
- …testable and measurable. + Defines, plans and leads activities, including, test method & measurement system development and validation , fixture design and ... Twitter . **The Staff Engineer, R&D - Verification and Validation , is the technical lead in the design verification...ensure design input requirements are satisfied to all relevant Quality System and regulatory requirements. + Defines and leads… more
- embecta (Andover, MA)
- …appropriate product certifications. + Defines, plans and leads activities, including, test method & measurement system development and validation , fixture design ... Twitter . The Staff Engineer, R&D - Verification and Validation , is the technical lead in the design verification...ensure design input requirements are satisfied to all relevant Quality System and regulatory requirements. + Definesand leads the… more
- Amgen (Holly Springs, NC)
- …authoring or owning change control records. + Experience with equipment and method validation , verification, and transfer including the change control ... as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Associate Quality Control Support **Live!** **What you will do** Let's do this. Let's… more
