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Quality Inspector in Marlborough,Ma
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Quality Assurance Auditor

Integrated Resources, Inc Shrewsbury Contractor
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Title : Quality Assurance Auditor

Location : Shrewsbury, MA

Duration : 4 months (with possibilities of extension)


Job Description:-


•     Perform data audits to assess that records  are attributable,  legible,  contemporaneous,  original, accurate,  and in  compliance with regulations,  international  standards,  SOPs, protocols/batch records,  and corporate policies and procedures.

•     Review SOPs,  protocols/batch  records,  reports,  and other quality and regulated  records for accuracy,  completeness,  and compliance with all applicable regulations,  international standards, and corporate policies and procedures.

•     Maintain written and signed records of all audits and inspections as required  and may sign records documenting the performance of audits and inspections and reporting  to management.

•     Participate in the preparation  and review of study/batch record and QA files in  preparation for sponsor/client site visits;  assure that QA audit files are retained.   May participate  in  the hosting of client site visits and support regulatory inspections.

•     Participate in  the development of corrective and preventative actions to respond to client visit and regulatory  inspection findings.

•     Identify,  document,  and report deviations from regulations,  protocols/batch  records,  SOPs, and specifications.

•     Review protocols and batch records and reports to assure accuracy, completeness,  and compliance with regulations,  international standards,  and company policies and procedures.

•     Independently perform  inspections and audits to monitor processes,  facilities, equipment, personnel,  materials, methods,  practices,  records,  and controls to assure compliance with regulations and international standards.

•     Participate in  inspections and audits of subcontractors,  vendors,  and suppliers of products and services.

•     Assist in  scheduling and tracking  QA audits,  inspections and procedures as requested.

•     Maintain written records for all statistical sampling  and testing of product if tested in manufacturing  areas.

•     Participate in  manufacturing  line clearances and verification of room acceptability prior to product manufacture.



Qualifications:-

  • Bachelor's degree (B.A./B.S.) or equivalent,  preferably  in  a life science or related discipline.

Experience:-

  • 1-2  years’ experience in  QA role.

Skills required

Conduct Inspection
Auditing
Internal Controls
Internal Auditing
Audit Planning
Auditing Standards

Location

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$99K
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Quality Assurance Auditor
Estimated Salary: $81K
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