Location: Remote with onsite travel to Raritan, NJ site.
Duration: 6 months with possibility of extension.
Start Date: ASAP
Job Description: Client is looking to actively prepare for upcoming audit in Q3 and is looking for a specialized individual to come in and help them for the next 6+ months. Needs someone well versed in procedures for changes in SOPs and gap assessments for quality documents to make recommendations on where to improve. The job could be fully remote but will require onsite visits to client facility, especially during time of Audit (therefore local is preferred). Candidates must come with Audit experience where they have been a lead auditor or supporting auditor (could be for internal, external, supplier, etc.). Looking for candidates who have an ASQ CQA, but does not have to be current/up to date. MUST have performed audits in the last 3 years though. Also looking for this person to be well versed in Risk Management (Risk standards ISO14971 and ISO31000). Also looking for experience in Trackwise. Big PLUS would be if the candidate speaks fluent Spanish as they have a lot of colleagues in Latin America and a lot of documents / SOPs in Spanish so being bi-lingual would be great but certainly not a requirement.
Skills: Audit, Inspection, Risk, CQA, Assessment, SOP
Education: BS or MS in related field.
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Audit Readiness Specialist (232875) Remote