Quality Assurance Generalist

Quality Assurance Generalist:
We are looking for a detail-oriented quality assurance specialist to be in charge of GMP and GCP quality assurance activities. The quality assurance specialist's responsibilities include supporting GMP and GCP audits, processing CAPAs, Deviations using the client's QMS system MasterControl.

Responsibilities:
Need to Support audits, both GMP & GCP audits.
Moving deviations and CAPAs through the system
Work within MasterControl to process CAPAs, Deviations and other quality records.
Performing routine inspections and quality tests.
Ensuring that standards and safety regulations are observed.
Addressing and discussing issues and proposed solutions with superiors.
Documenting quality assurance activities and creating audit reports.
Creating training materials and operating manuals.

Requirements:
High school diploma/GED required.
Degree preferred.
Certificate in quality assurance is a plus.
Previous experience in quality assurance or a similar field.
Working knowledge of tools, methods, and concepts of quality assurance.
Solid knowledge of relevant regulatory standards.
Good communication skills, both verbal and written.
Excellent data collection and analysis skills.
Strong attention to detail.