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Quality Auditor Principal-26031  

Schedule and conduct internal audits, support external agency inspections (eg FDA, EMA, TGA and others), and external vendor/supplier audits and inspections.
Prepare audit reports and initiate the subsequent corrective action requests.
Assist in the management of external audits.
Responsible to track and trend key audit program metrics, and to report at management review meetings. (eg GLP, GMP, GCP, and/or ISO 13485 compliance evaluations.).
Examine and interpret documentation for new and current compliance procedures and regulatory enforcement trends/actions.


This position assists in solving compliance problems with Research & Development, Quality Assurance, Quality Control, Quality Systems, Facilities, and/or Manufacturing.
Participate in determining divisional compliance policies, training, mentoring and coordination of other compliance auditors.
Conduct follow-up audits when necessary to non-compliance issues, requiring the ability to coordinate audit teams.

Skills and Competencies:
Demonstrated strong writing, verbal and interpersonal communication skills; excellent attention to detail; excellent analytical and problem solving skills; proficient computer skills; high commitment to assignments and capability of working independently with the ability to lead audit teams; must be able to remain focused in a dynamic environment.

Work is performed under general direction of a department Manager.

BA/BS degree in a scientific discipline or equivalent relevant experience.
Knowledge of regulations for medical devices and biopharmaceuticals (cGMPs, 21 CFR 211, 21 CFR 600, 21 CFR 820, ISO 13485, and EU regulations),
Knowledgeable of ANSI/ASQC sampling procedures.
Knowledge of Good Laboratory Practices (GLP) and audit program software a plus.
ASQ/RAB certified as either a Lead Auditor or Biomedical Lead Auditor preferred.
User experience with TrackWise, FilMaker Pro and other qualtiy systems management software.
5-7 years experience as a Lead Auditor in the Life Sciences industry.

Job: Quality
Primary Location: United States-Massachusetts-Framingham
Shift: Day Job
Job Type: Regular
Employee Status: Regular
LocationUnited States-Massachusetts-Framingham
CountryUnited States of America
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Posted Date05/26/2011 01:04:42
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