DUTIES AND RESPONSIBILITIES:
Quality, Regulatory & Safety – EO
Provides information and data reflecting the status of the plant quality system
Assists with corrective action and process improvement activities and assists in appropriate re-training
Monitors the quality and integrity of information required for the sterilization process history record (a batch record)
Issues release of processed materials
Assists in all activities relevant for FDA, customer and regulatory audits
Assists with the monthly review of the Total Quality Management Report
Assists with audits to ensure FDA/ISO/GMP compliance and to provide a basis for continuous improvement
Assists with Quarterly Environmental monitoring of employees
Executes equivalency and retrospective re-validation studies/reports
Assists the Validation Coordinator with validations and calibrations
Analyzes temperature and humidity probe data
Other QA/Validation duties as assigned
Maintains all quality-related training programs
Quality, Regulatory & Safety – Gamma & e-Beam
Performs the batch review and approval
Performs density studies on customer products and complete applicable tote loading diagrams
Assists the QA Manager in the calibration of instruments used in safety and dosimetry systems and performance of quality control procedures
Assists the QA Manager in scheduled quality audits and “as needed” customer product inspections
Provides backup support for the QA Manager in a variety of functions
Reviews and release of the production run in MIS system
Maintains Customer Master Files & Training records
Conducts Housekeeping audits in accordance with written procedures
Assists with other tasks assigned by Supervisor
EDUCATION, EXPERIENCE & SKILL REQUIRED:
High School Diploma or a combination of education and experience
One (1) to 1.5 years of experience working in a sterilization environment preferred
Must be able to read, write and speak fluent English
Should be proficient using a computer and be able to analyze data in a database/spreadsheet
Must be willing to work established shifts
CLICK TO APPLY
Pure Staffing Solutions Inc. represents the full spectrum of staffing services for qualified personnel to meet the evolving needs of companies - from small, emerging growth companies to Fortune 500 clients; no challenge is too big or too small. Our success springs from our dedication to service, which is based on our understanding that strong, lasting relationships are the cornerstones of any successful business. Our thorough, ethical handling of the staffing process makes for achievements that speak for themselves.