- 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
- Penn Medicine (Philadelphia, PA)
- …at the Hospital of the University of Pennsylvania is seeking a Technical Specialist in Electron Microscopy to join their team:** **Summary:** The incumbent's primary ... functions of the electron microscopy laboratory. Using an ultra-microtome, the specialist will perform gross microscopy, fixation, processing and embedding of… 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
- 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
- Fresenius Medical Center (Lexington, MA)
- PURPOSE AND SCOPE: The Senior Quality Specialist plays a pivotal role in maintaining and enhancing the quality management system (QMS) within the IT department. This ... GMP, ISO 13485) as well as documenting computerized system validation and regulatory requirements (GMQ Annex 11, CFR 21...11, CFR 21 Part 11, GAMP) + Understanding the method for the management of IT departments providing GxP… more
- Veterans Affairs, Veterans Health Administration (Aurora, CO)
- …these when drawing conclusions about the validity of testing results. Performs validation / method verification studies for new systems. Consults with healthcare ... responsibilities and may have responsibility for a specific large scale automated analytical system; a specific area of laboratory functions, such as employee… more
- Cummins Inc. (Troy, MI)
- …areas critical to success in the role. + Operates as a recognized specialist in a discipline or product area within the immediate team. **QUALIFICATIONS** **To ... and recommended actions to prevent problem reoccurrence. + Product Verification and Validation Management - Develops product systems validation plans from a… more
- Orchard Therapeutics (Boston, MA)
- …lab vendor selection, contracting, and lab/sample/assay management. . Review and approve method development and/or validation reports prepared by lab vendors. . ... clinical team to provide key expertise in study specific, potentially specialist , bioassay set-up and implementation. Key elements and responsibilities . Serve… more