Requirement:
A?brief?summary?ofduties?you?will?be?involved?in?as?Senior?QA?Auditor：
1.?Schedules,?conducts,and?documents?assigned?audits?of?the?Company’s?projects?and?operationalprocesses?in?accordance?with?approved?procedures,?schedules,?and?formats.
2.?Hosts?Sponsor?auditsand?assists?senior?QA?personnel?in?Regulatory?Authority?inspections?perCompany’s?policies?and?procedures.
3.?Writes?and?issuesaudit?reports?in?accordance?with?standard?Company?formats?and?timelines
4.?Reviews?responses?toaudit?findings?for?appropriateness?and?completeness.?Follow?up?as?appropriateto?obtain?audit?response.
5.?Maintains?accurateand?timely?documentation?of?QA?auditing?activities.
6.?Serves?as?a?trainerand?mentor?to?less?experienced?QA?Auditors.
7.?Serves?as?LeadAuditor?on?team-based?audits?and/or?for?project?audits.
8.?Manages?assignedquality?issues?in?accordance?with?Company?requirements.
Qualifications:
To?succeed?in?this?roleyou?will?need?the?following?skills/experience:
BA/BS?degree?in?thescience/health?care?field?or?equivalent?combined?education?and?experience.
Extensive?experience?inclinical?quality?assurance?auditing?and?conduct?of?vendor?audits?(e.g.?ofcentral?laboratories,?clinical?suppliers,?IRBs,?etc.).
Strong?knowledge?of?allapplicable?Good?Clinical?Practice?regulations?and?guidelines.
Knowledge?of?medicalterminology?preferred.
Well-developedcommunication?skills?and?the?ability?to?write?and?present?concise,?accuratereports?and?other?necessary?documentation.
Ability?to?handlemultiple?tasks?to?meet?deadlines?in?a?dynamic?environment.
