- BioAgilytix (San Diego, CA)
- …role/operations Not less than three (3) years' experience in GLP /GCLP/GMP quality assurance (QA) Experience working in biotech, pharmaceutical, CRO/CMO ... or similar organizationSkills: Internal and/or external GxP auditing experience Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner Excellent verbal and written communication skills Ability… more
- BioAgilytix (Durham, NC)
- …laboratory/bench role/operations Not less than two (2) years' experience in GLP /GCLP quality assurance (QA)Experience working in biotech, pharmaceutical, CRO/CMO or ... similar organizationMinimum Preferred Qualifications - SkillsInternal and/or external GxP auditing experienceAbility to work in fast-paced environment where multiple projects are in process and must be completed in a timely mannerExcellent verbal and written… more
- Actalent (Cincinnati, OH)
- Job Title: GLP Auditor Description: + Monitoring each GLP study to assure management that the facilities, equipment, personnel, methods, practices, records, ... and controls are in conformance with the GLP regulations (21 CFR Part 58). + Assessing Vendors...regulations (21 CFR Part 58). + Assessing Vendors for GLP Compliance and monitoring studies performed at the vendors… more
- Actalent (Cincinnati, OH)
- …+ Monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the ... regulations. + Assessing Vendors for Compliance and monitoring studies performed at the vendors + Providing audit reports for audits / assessments performed. + Assisting as necessary with the internal activities to conform with the regulations + Maintaining… more
- Actalent (Cincinnati, OH)
- …will be as follows: . Support team to investigate and resolve issues related to equipment failures, system deficiencies, deviations, and equipment troubleshooting. . ... Support authoring quality systems records such as deviations, change controls, CAPAs as required . Monitor and communicate method lifecycle (acquisition, qualification / validation, implementation) timelines using project management tools. . Ordering supplies… more
- Curtiss-Wright Corporation (Summerville, SC)
- …May assure compliance to in-house and/or external specifications and standards (ie GLP , GMP, ISO, Six Sigma). May prepares and provide product assurance ... 9001, NQA-1, or 10 CFR 50 compliant quality programs * ISO 9001 Certified Auditor * Ability to understand statistical inference * Good presentation skills * Previous… more
- Amgen (Thousand Oaks, CA)
- …Operations and/or Quality experience **Preferred Qualifications:** + Experience as an auditor , preferably in Good Clinical Practice (GCP), Good Laboratory Practice ( ... GLP ) and/or Good Pharmacovigilance Practice (GPvP) + Verbal and Written Communication + Teamwork + Time Management + Interpersonal Skills + Analytical Skills +… more
