Quality Control Operator I PreAnalytics

Your challenge

12 Hours Day Shift - Rotating Schedule

Responsibility:     
•    Carry out QC testing and examination according to valid procedures.
•    Carry out Incoming Goods Inspection according to valid procedures
•    Preparation of solutions and equipment for production according to valid TP’s and SOP’s as required
•    Cleaning and sanitation of Laboratory / QC areas
•    Perform QC Inspections on the Manufacturing floor 
•    Issue a QIR for non-conforming product.
•    Test non-conforming product to resolve QIR issue’s as well as investigate returned products via complaint processing system.
•    Perform equipment calibration.
•    Perform routine inventory (e.g., chemicals, supplies, etc) for lab.
•    Assist in maintaining inventory database and SAP inventory 
•    Assist in ordering chemical and lab supplies.
•    Other duties as assigned.

Authority:
•    Evaluation of products in the production according to valid QMI documents.
•    Restriction of non-conformity product according to appropriate QMI documents.
•    Release of product according to valid QMI documents.
•    Release incoming goods according to valid Certificate of Analysis (e.g., Nipro, BCA, EDTA, Safety Blood Collection Set).
•    Release sterilization.
•    Release of solutions.
•    Perform SAP transactions to Hold and release product.

Your Profile

Job Requirements:
•    High school education or equivalent; Degree is preferred with at least 1 year of relevant work experience.
•    Experience in Medical Device, Pharmaceutical, and/or regulated industry is preferred
•    Must have sufficient communication and writing skills. 
•    Must have been QC trainee for a period of 3 months.
•    Must pass pre-employment test.
•    Basic computer knowledge and MS Office skills.

Physical Requirements:
•    Must be able to stand and walk for up to 8/12 hours. 
•    Must be able to lift up to 70 lbs.
•    Must have appropriate vision to perform detailed quality inspection as outlined in SOPs and TPs.