Job Summary

Quality Assurance Specialist

The Quality Assurance Specialist (QAS) will work within the Quality Assurance department to

provide review of device/product records to ensure compliance to applicable federal, state, local,

and accreditation standards. The QAS will audit Device Master Records (DMR), Design History

Files (DHF) and Device History Records (DHR) for compliance and release criteria. The QAS

will also contribute to compliance activities of the Globus quality system and participate in

continuous improvement activities. The position responsibilities may include the following,

although other duties and responsibilities may be assigned as necessary:

RESPONSIBILITIES:

Perform Device History Record review and release functions
Audit Design Master Records and Design History Files
Review certificates of compliance or test reports
Review technical and performance specifications
Review receiving inspection documentation
Report non-conformances and discrepancies
Create formal audit reports
Generating Excel Spreadsheets
Participate in continuous improvement functions and implement changes for improved
Other duties and responsibilities as necessary

QUALIFICATIONS:

1) Bachelor’s Degree

2) Experience performing file reviews and/or audits.

3) QA or QC experience within the biotech industry preferred.

4) Knowledge of GMP regulations preferred.

5) Must be knowledgeable with Microsoft word and Excel programs.

6) Must have ability to evaluate and interpret technical data

7) Must be able to lift at least 25 lbs.

8) Strong typing skills, analytical skills, and problem solving techniques.

9) Excellent communication and writing skills.