QA Investigator II

This position requires the following requirements for employment at Stallergenes Greer and includes but not limited to:

Primary Responsibilities

Technical writing

Creation of general business documents and procedures

Understanding of applicable governmental regulations

Participates in internal and external audits, travel may apply

Communicates issues to Quality Management

Ability to collaborate as a member of cross-functional teams

Support regulatory inspections

Support media fills

Additional tasks as required

Performs/reviews the following as applicable by functional unit:

Deviations

Complaints

Discrepant Material reports

Laboratory Out of Limits

Building Monitoring System Out of Limits

Calibration Out of Tolerance

Product Out of Yield

Corrective/Preventative Action reports

Critical System Work Orders

Change Notifications

Change Requests

Document revisions

Protocols

Compilation of metrics

Physical Demand(s)

The physical demands described here are representative of those that could be required of an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requires Type 4 Garb qualification (Sterile Containment Suit, Sterile Hood, Sterile Face Mask, Sterile Gloves, Sterile Boots, and Sterile Goggles).

While performing the duties of this job, the employee is frequently required to sit, talk, and hear.

Must be able to pass visual acuity test

Computer Skill(s)

General use of Microsoft® Word and Excel