Quality Assurance Investigator

Specific Job RequirementsTechnical writing skillsCritical thinking skills and detail orientedCreation of general business documents and proceduresUnderstanding of applicable governmental regulationsParticipates in internal and external audits, travel may applyCommunicates issues to Quality ManagementAbility to collaborate as a member of cross-functional teamsSupport regulatory inspectionsSupport media fillsAdditional tasks as requiredPerforms/reviews the following as applicable by functional unit:DeviationsComplaintsDiscrepant Material reportsLaboratory Out of LimitsBuilding Monitoring System Out of LimitsCalibration Out of ToleranceProduct Out of YieldCorrective/Preventative Action reportsCritical System Work OrdersChange NotificationsChange RequestsDocument revisionsProtocolsCompilation of metricsEducation Requirements· Bachelor's degree in a scientific fieldWork Experience Requirements· 2-5 years of pharmaceutical manufacturing experience (or post-secondary education) is requiredPhysical DemandsThe 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.Specific vision abilities required by this job include close vision and ability to adjust focus.Must be able to pass visual acuity testComputer SkillsTo perform this job successfully, an individual should have basic computer knowledge such as Word Processing and Database software as well as Edwards or equivalent inventory softwar

Created: 2025-10-02