- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …+ **Participate in the development and review of the Clinical SOPs, Regulatory documents and Study Plans** + Participate in the Clinical SOPs periodic reviews as well ... as in the creation of new procedures + Participate in the study plans reviews + Participate in the review of Regulatory Documents (Clinical Study Protocol, Investigators Brochure, Informed Consent Form, Clinica Study Report) + **Provide quality oversight on… more
- ZOLL Medical Corporation (Raleigh, NC)
- …customer with application of equipment. + Escalates customer related issues to CQA Regional Management + Performs trouble-shooting on-site and corresponds with ZOLL ... Projects as assigned. + Participate in customer meetings with service management and CQA regional managers to address concerns and formulate action plans. + Annual… more
- Reckitt (Wilson, NC)
- …+ Ensuring Critical Process Parameters (CPP's) and Critical Quality Attributes ( CQA 's) are considered during early-stage technology transfer (TT1/2), providing input ... on supply equipment ordering, facility start-up and process transfer risk assessments + Leading and managing a team of scientists to execute R&D laboratory start-up, maintenance and analytical method transfer activities, working in close partnership with R&D… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …by USFDA. Perform IOQ/Calibration for instruments in QC lab at Monroe with guidance of CQA . Execute and complete procedures and systems for RM, PM, FD and in process ... testing in QC lab. Provide information, data for evaluation and execution of stability study as per Quality and regulatory requirement. Timely complete testing and ensure compliance during analytical TT and AMV performed in QC lab. Able to be a qualified… more
- 3M (Monroe, NC)
- …certification(s): Certified Quality Engineer (CQE), Certified Quality Auditor ( CQA ), Certified Manager of Quality/Organizational Excellence (CMQ/OE) + Green ... Belt and/or Black Belt experience + Communication, writing, influencing, and conflict resolution skills **Work location:** + Monroe, NC **Relocation Assistance: May be authorized** **Must be legally authorized to work in country of employment without… more
- ThermoFisher Scientific (Greenville, NC)
- …& empower a team/peers + Technical Writing experience + Professional certifications (ex: CQA ) and training (Six Sigma) are a plus + Primary responsibilities require ... consistent production floor presence which necessitate physical fitness for prolonged standing, walking, and repetitive bending, and aseptic and non-aseptic gowning. **Physical Requirements:** Position requires ordinary ambulatory skills and physical… more
- ThermoFisher Scientific (Greenville, NC)
- …understanding of quality systems and technical writing. + Professional certifications (eg, CQA ) and training in Six Sigma are beneficial. + Demonstrated commitment ... to fundamental principles of Integrity, Respect, and Excellence is essential. + Ability to work independently and to remain firm in complex situations is required in this fast-paced environment. **Physical Requirements/ Work Environment** Position requires… more
- ThermoFisher Scientific (Greenville, NC)
- …effective verbal and written communication skills. + Professional certifications (ex: CQA ) and training (Six Sigma) are a plus. **Physical Requirements:** Position ... requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of… more
- Teleflex (Morrisville, NC)
- …**Specialized Skills / Other Requirements** * ASQ certification preferred (eg CQE, CQA , CMDA, CRE, CSSGB/CSSBB). * Strong understanding of industry regulations such ... as ISO 13485, ISO 14971 and FDA 21CFR820. * Proficient in MS Office, and Minitab or other statistical softwares. * Strong organizational and time management skills to meet deadlines while managing multiple projects. * Strong analytical and critical thinking… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …by USFDA. Perform IOQ/Calibration for instruments in QC lab at Monroe with guidance of CQA . Execute and complete procedures and systems for RM, PM, FD and in process ... testing in QC lab. Provide information, data for evaluation and execution of stability study as per Quality and regulatory requirement. Timely complete testing and ensure compliance during analytical TT and AMV performed in QC lab. Able to be a qualified… more