- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- Job Title Analytical Method Validation Specialist Requisition JR000014442 Analytical Method Validation Specialist (Open) Location St. ... MO Additional Locations Job Description Summary The analytical method validation review specialist is responsible for conducing comprehensive reviews… more
- Astellas Pharma (Westborough, MA)
- … Validation + Analytical Equipment Qualification/ Validation + Analytical Method Validation + Authors and/or approves technical documents ... **Senior Validation Specialist , Quality Assurance** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every… more
- Catalent Pharma Solutions (Harmans, MD)
- …Development and Quality Control departments of our Contract Manufacturing Organization, performing analytical method development and review of data generated as ... **Senior Specialist , QA Analytical ** **Position Summary** Catalent...of Catalent. * Provide quality oversight of process and analytical method development in an R&D setting… more
- Merck (De Soto, KS)
- …and ELISAs + Leads and/or provides technical support in the development and validation of in vitro analytical tests, including experimental design, in ... investigations for in-line Quality Control assays + Supports and/or leads method improvement lab activities across multiple test platforms including live virus… more
- Bristol Myers Squibb (Devens, MA)
- …of in-process, final product, and stability samples. * Perform testing for method transfer/ validation /verification. * Perform data verification, data review and ... and stability samples, including data review/verification. May assist with method transfer, documentation, deviations, investigations, and continuous improvement efforts.… more
- Saint-Gobain (Portage, WI)
- …or equivalent, assisting in validation activities, and writing applicable test method reports. The Metrology Specialist will also analyze and test various ... our efforts on the world around us. **The Metrology Specialist works with engineers to devise ways to measure...(and measuring qualification/ validation parts, as needed), developing method validation protocols such as Gage R&R… more
- Gilead Sciences, Inc. (La Verne, CA)
- …mitigation plans as needed + Review and approve biological test methods and method validation /transfer reports + Review and approve lab investigations associated ... motivated individual to join us as a Sr. QA Specialist for the Gilead La Verne Quality Assurance Department....with release testing and method validation /transfer at the site or contract… more
- Boehringer Ingelheim (Fremont, CA)
- …escalate to upper management, and provides compliant and smart solutions for complex validation issues. + Expert understanding of analytical methods and ... Binding assays), Residual Impurities, Physicochemical/Drug Product, or Raw Materials/Cleaning validation /verification. Provides technical oversight, coordinates and reviews analytical… more
- Amgen (Holly Springs, NC)
- …the startup and validation of the laboratory equipment and transfer of analytical methods as well developing a diverse team of individuals to deliver site start ... and reports including SOPs, safety assessments, methods, trend reports, qualification/ validation summary reports, technical reports, and method assessments.… more
- Cardinal Health (Indianapolis, IN)
- …stability protocol(s) at the prescribed cadence. + Authors standard operating procedures, analytical method worksheets, forms and other documents as necessary ... + Performs investigations, deviations, change controls and CAPAs. + Execute method verification, validation and/or transfer protocols. + Perform stability… more
- Cambrex High Point (Durham, NC)
- …and medical device testing, compendia methods (eg USP/NF, EP, JP), and method validation /qualification/transfer, as required. Skills / Abilities: + Demonstrate ... organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more...You Matter by applying today! Job Overview The QA Specialist II supports the Quality Management System (QMS) and… more
- Gilead Sciences, Inc. (La Verne, CA)
- …in support of commercial products. Responsibilities include technical leadership of analytical method validations/ transfers for Biologic Products and leading ... binding assays. + Strong cell - culture experience and knowledge. + Experience in method validation / method transfers is required. + Experience with LIMS,… more
- Penn Medicine (Philadelphia, PA)
- …Pathology and Laboratory Medicine has an exciting opportunity for an experienced Technical Specialist in its Electron Microscopy lab which is located in the Gibson ... Electron Microscope - 3400 Spruce Street) **Responsibilities:** + **Technical Services:** Monitors pre- analytical , analytical and post analytical phases of… more
- PNC (Chicago, IL)
- …to contribute to the company's success. As a Portfolio Analytics & Strategy Specialist within PNC's Retail Lending Decision Science organization you will use data ... combine their knowledge of the consumer lending business, operational execution and analytical techniques to craft actionable strategies that drive results in the… more
- State of Georgia (Decatur, GA)
- …resistance lab network) and Emerging Infections Program (EIP). Assist with method validation and performance verification for Laboratory developed methods ... Medical/Clinical Specialist 3 Georgia - Decatur (https://careers.georgia.gov/jobs/56785/other-jobs-matching/location-only) Applied Science… more
- Actalent (Norwood, MA)
- …deviations, change controls, CAPAs as required . Monitor and communicate method lifecycle (acquisition, qualification / validation , implementation) timelines ... QC Equipment Specialist As part of the QC Equipment team,...experience in a cGMP laboratory setting * Familiar with analytical equipment troubleshooting and maintenance * Strong skills with… more
- Eurofins (Cambridge, MA)
- …molecules. + Basic understanding of industry practices and standards. + Experiences on method development and validation for synthetic molecule products + Strong ... Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and… more
- Actalent (Norwood, MA)
- …deviations, change controls, CAPAs as required . Monitor and communicate method lifecycle (acquisition, qualification / validation , implementation) timelines ... of industry experience in a cGMP laboratory setting . Familiar with analytical equipment troubleshooting and maintenance . Strong skills with GMP/GDP/QC Data review… more
- Penn Medicine (Philadelphia, PA)
- …are maintained for each determination performed. Responsibilities: + Technical Services: Monitors pre- analytical , analytical and post analytical phases of ... trends in patient data and quality control data to determine proper instrument/ method performance; As assigned, develops new assays through to validation ;… more
- Veterans Affairs, Veterans Health Administration (Gainesville, FL)
- …Develops protocols for performance of tests and evaluation of results. Performs validation / method verification studies for new systems. Consults with healthcare ... targeted laboratory responsibilities or projects such as laboratory safety officer, analyzer specialist , or quality control file maintenance. At the GS-10 level, MTs… more